SUMMARY OF RESULTS FROM
MEDICAL STUDIES The development of a proprietary liquid nutrient concentrate and weight management program began with an analysis of what per FDA and FTC guidelines is considered a bona-fide weight loss system. From a regulatory point of view, for the purpose of advertising, weight loss is the result of two factors: Reduced calorie intake;
Exercise to stimulate the burning of calories.
The liquid nutrient concentrate (a food product) was formulated to help a dieter do this: (1) be a meal substitute to reduce the caloric intake, and (2) provide sufficient nutrition so that a dieter feels energetic enough to do some form of daily exercise. A weight loss program was then designed based on these two points. The effects of that program—both on weight loss and overall health—has now been studied in four medical studies, plus a short clinical observation report. MEDICAL TRIAL #1: The purpose of the first medical study was to see if using the liquid nutrient concentrate together with a strict reduction in two of the three meals per day would produce safe and effective results after only one week. The results showed a significant loss of weight and reduction in body measurements, as well as improvements in several blood values: Weight loss: 7.5 lbs
Body fat percentage reduction: 3.02%
Waist size reduction: 2.32 inches
Hips size reduction: 2.80 inches
Chest size reduction: 1.93 inches
Abdomen size reduction: 2.45 inches
Glucose reduction: 3.17 mg/dL
Total cholesterol reduction:5 mg/dL
Triglycerides reduction: 22.31 mg/dl
MEDICAL TRIAL #2: The second study was carried out to see if a dieter could comfortably use the liquid nutrient concentrate for a longer period of time than one week (four weeks) without secondary effects such as tiredness or feelings of hunger. The dietary modifications were also not as strict as in the previous study: Only one meal per day was replaced by the nutrient concentrate. Weight loss: 7.48 lbs
Waist size reduction: 2.75 inches
Hips size reduction: 2.32 inches
Chest size reduction: 2.56 inches
An observation from this study was that the greater the starting weight of a participant, the greater was the weight lost. Some obese participants lost over 20 pounds during the trial. MEDICAL TRIAL #3: The third trial was made to see if the liquid nutrient concentrate could improve lipid (fat) metabolism at a very early stage of being overweight. This study also had no dietary modifications other than using the nutrient concentrate in lieu of breakfast.
Weight loss: 4% (5.72 lbs)
Waist size reduction: 5.4% (1.73 inches)
Buttocks size reduction: 2.6% (0.94 inches) Rump size reduction: 3.2% (1.18 inches)
Blood pressure reduction: 1.6%
Total cholesterol reduction: 4.7%
LDL cholesterol reduction: 2.0 %
Triglycerides reduction: 29.5%
Blood glucose reduction: 12.1%
Insulin reduction: 12.6%
SGOT activity decrease*: 1.4 %
SGPT activity decrease*: 3.3%
* Decrease in the activity in these liver enzymes indicate that the nutrient concentrate may have systemic cleansing or detoxifying effects. MEDICAL TRIAL #4: The fourth clinical took place over a period of six weeks to study both the weight loss results and overall health benefits to a dieter over this longer period of time. This study began with a three-day initial cleansing program with the nutrient concentrate as the only source of nutrition, followed by five and a half weeks of using the concentrate to replace one meal per day. Weight loss: 28.4 lbs
Adipose tissue reduction: 6.7%
Average total cholesterol reduction: 20.6 mg/dL
Average triglyceride reduction: 18.3 mg/dL
In addition, those participants with high liver enzyme values saw these normalized during the trial. SHORT CLINICAL OBSERVATION: A clinical observation trial with 13 participants showed that twelve of the 13 were able to normalize abnormal liver enzyme values (SGPT and SGOT) after using the nutrient concentrate for two weeks. Those twelve subjects were also able to lose a significant amount of weight during the two-week period (10-15 pounds).
PATENT PENDING: Based on these clinical results, a patent that covers any combination of the ingredients in in the nutrient concentrate in liquid form as a “method for preventing or treating preobesity and obesity and metabolic conditions associated with pre-obesity and obesity” has been filed with the US Patent and Trademark Office. During the review of the application by the USPTO, the invention enjoys full patent protection.
Medical Trial #4
The effects of a 6 week weight management program,
utilizing non-pharmaceutical nutritional supplements,
on weight reduction, subjective energy level, cholesterol,
triglycerides, adipose tissue and liver enzymes in obese adults.
Dr. Gerald W. Lane, Medical Director & Primary Research Investigator
Institute for Metabolic Research, Columbus, Ohio
Dr. Lane is Administrative Director of Research at The Institute for Metabolic Research, Columbus, Ohio. He is a graduate of Ohio University College of Osteopathic Medicine, Athens, Ohio. He is former Medical Director for Hilltop Research and Radiant Research, Columbus Ohio. Dr. Lane has contributed toward greater than 250 clinical research projects over 15 years. Past Clinical Associate Professor of Medicine, Ohio University, College of Osteopathic Medicine, Athens, Ohio
Key words: weight management, obesity, nutritional supplements, liver enzymes
Abstract
A nutritional supplement program studied 35 participants to determine safety and efficacy of the products (a liquid nutrient concentrate) while measuring weight reduction, lipids, adipose tissue and liver enzymes over a 6 week period. This was an open label trial with obese adults which measured total weight, percentage of body fat,
andropometric measurements of mid-arm circumference, abdomen, hips, thighs, caliper measurements of skin folds
of triceps, supraliac and mid-thigh (female) and caliper measurements of skin folds of chest, abdomen and mid-thigh (males), electrolytes, glucose, cholesterol, triglycerides, albumen, total protein, bilirubin, BUN, Creatinine, SGOT, SGPT, and subjective energy levels (self reported by participants). The group participated in a 72 hour program utilizing only the nutritional supplements and hydration. The results were remarkable. Every subject in the program lost weight with an average weight loss of 8.7 pounds. They then continued to utilize the nutritional products to replace one meal per day for 39 additional days. The average weight loss after 14 days was 18.2 pounds and 28.4 pounds at the conclusion of the 6 week trial.
Patient’s metabolic functions were closely monitored in order to document therapeutic benefit, while monitoring for potential side effects. Total cholesterol was lowered in all participants (ave. reduction = 20.6) and every participant with clinically elevated cholesterol (≥ 200) at baseline, reported normal values after 6 weeks. Similarly, all participants with fasting hyperglycemia (s. glu. ≥ 100) returned to normal by the end of the study. This included 3 patients with NIDDM who were not well controlled prior to the study. There was no evidence of hypoglycemia (s. glu. ≤ 65). Participants with elevated liver enzymes at baseline reported normal SGOT & SGPT levels after 2
weeks. No participant developed liver enzyme elevations. Subjective energy level of the participants was reported
at baseline as low to average and reported as high to very high at the conclusion of the study. All participants lost
total adipose tissue with the average change calculated at 6.7% lost. Decrease in total inches of body fat paralleled
that of weight. For each pound of weight lost, the participants lost 0.82” off of body measurements.
Introduction
Obesity is the number one contributor to the development of heart disease, diabetes mellitus and atherosclerosis in developed countries. The toll on human existence, both medically and economically is immense. While we cannot alter genetic factors contributing to obesity, cholesterol and triglycerides and diabetes, we can successfully address the exogenous contribution to these disease states. Pharmaceutical attempts to promote weight loss have historically been accomplished via appetite suppressants that many times are addictive and or have cardiovascular side effects. The prescribing patterns of these medications are closely monitored by the board of pharmacy in most states, due to abuse and miss-use by patients and prescribers. This study was conducted to document scientifically an effective and safe mechanism to help obese individuals lose weight. The results of this study bear out that there are safe, effective adjuncts to weight loss without the need for prescription medication or frequent physician visits.
Methods
Inclusion in the study required that all subjects were obese adults, between the age 18 and 65, whose weight was at least 15% over IBW (ideal body weight). IBW for males was calculated utilizing the formula: 106# for the first 60” of height and 6 # for each additional inch, plus or minus 6#’s. Females utilize the formula: 100# for the first 60” and 5# for each additional inch, plus or minus 5#’s. Examples: a male 5’ 8” (68”) would have an IBW of 148-160. A female of 5’8” (68”) would have an IBW of 135-145. Study participants would be equal or greater than 15% more than the upper limit of the IBW range. The male in the above example would have to weigh ≥ 184 (15% greater than 160) and the female would have to weigh ≥ 167 (15% greater than 145). The study sample consisted of 35 qualified and consented subjects, 2 females and 8 males. The average percentage over IBW was 21% (range of 15% - 45%). The first study participant was enrolled on August 22, 2010. All participants received a general physical exam, anthropological body measurements utilizing the Jackson – Pollock scale. This included weight, body circumference measurements of arms, abdomen, hips and thighs plus body fat analysis with caliper measurements of arms, sacroiliac and thigh in females and chest, abdomen and thigh in males. Laboratory analysis included comprehensive metabolic panel + lipids at baseline visit, day 15 and upon conclusion of the study (day 42). On the first visit, the participants were started on the phase one of the study, which consisted of 3 dietary cleansers on day zero and the study products and protocol for days 1-3 (appendix 1 – phase 1). They returned on day 4, weighed, all measurements were repeated and they received the study products and protocol for days 4-42 (appendix 2 – phase 2). On days 15 and 42, they were seen for a follow up visit. Weight, body measurements and labs were repeated. All data was collected and the study was closed on November 15th, 2010.
Statistical Analysis
The data was analyzed using the statistical package SPSS version 12. A Kolmogorov-Smirnoff goodness of fit test was performed on all variables in the experimental group to test the null hypothesis that the data came from a normally distributed population. The results accepted the null hypothesis for all variables (p < 0.01). Next a parametric paired-sample t-test was carried out to determine that there is no significant difference between the mean of the initial measurements (i.e. before treatment) and the mean of the subsequent measurements (i.e. posttreatment). This test was performed for each variable included in the experimental group (treated with the dietary program). All results rejected the null hypothesis and the means were significantly different (p< 0.05). Also an analysis of variance was performed between the three measurements resulting in a significant difference (p < 0.01) among the three measurements. Finally, a Pearson coefficient was calculated to test the degree of correlation in the change detected between the pre and post-treatments. All results showed a significant coefficient (p< 0.01) consistent with the changes observed experimentally. Results
All measurements reported on the 35 subjects were taken 3 times during the study (at randomization day #1, day #14 and at the conclusion of the study, day #42). All subjects served as their own controls. Total body weight: Every subject in the program lost weight with an average weight loss of 8.7 (± 2.1) pounds. They then continued to utilize the nutritional products to replace one meal per day for 39 additional days. The average weight loss after 14 days was 18.2 (± 3.7) pounds and 28.4 (± 6.5) pounds at the conclusion of the 6 week trial. This was found to be statistically significant (p<.01) Adipose Tissue: The average % loss of adipose tissue was 6.7% (± 0.8). This difference was found to be significant (p < 0.01). Glucose: The average serum glucose at baseline was 93.76 mg/dL ± 1.89. Glucose at day 14 was 89.55 (± 1.80) and 92 (± 1.54) at the conclusion of 6 weeks. These numbers were not statistically significant. 3 participants with clinically significant hyperglycemia (fasting glucose ≥ 100) had normal values at the conclusion of the study. Of these 3 subjects, the baseline fasting glucose was 154.33 (± 22.67 mg/dL). These 3 subjects fasting glucose on day 42 was 94 (± 2.33 mg/dL). These findings were not statistically significant, however, clinically very revealing. Total cholesterol: The average loss of total cholesterol was 20.6 mg/dL (± 6.23). The total cholesterol at baseline was 192.2 mg/dL (± 8.05) and at day 42, was 171.6 mg/dL (± 5.67). This was found to be a statistically significant difference (p<0.01). Triglycerides: The average loss in triglycerides was 18.3 mg/dL (± 4.22) for 34 of the 35 patients. This difference had a statistical significance (p<0.05). Of particular interest was one participant whose baseline triglyceride was 1430 mg/dL (normal ≤ 149 mg/dL). The subject was notified of the “alert” values and was offered to be more closely monitored and to be referred to an independent physician for further evaluation. He chose to remain in the study. At day 14 his triglyceride level was reduced to 894 mg/dL, at day 28 was reduced to 782 mg/dL and at day 42 was reduced to 593 mg/dL. He experienced a reduction of 837 mg/dL of his triglycerides. This outlier is scientifically interesting, although not significantly significant. Upon conclusion of the study, he agreed to continue to remain on the study product and agreed to monitor of his triglycerides every 3 months. Discussion
This study was an open label clinical trial in which subjects served as their own control for a period of 6 weeks (42 days). The primary end points of the research were to assess the efficacy of a non-pharmacological weight loss
system while monitoring for safety. Secondary end points were to demonstrate if the studied products would
elucidate medically therapeutic changes in fasting glucose, cholesterol and triglycerides while monitoring hepatic
and renal functions for safety.
Each subject was monitored for changes in total body weight, percentage of adipose tissue (total body fat), waist, hips, chest measurements as well as glucose, SGOT, SGPT, albumin, total cholesterol and triglycerides.
Significant reductions were found in total weight loss, total body adipose tissue, cholesterol and triglycerides while participants experienced no clinically significant adverse effects. There were no elevations in hepatic function
studies and participants experienced normalization in SGOT, SGPT if those values were elevated at baseline.
Likewise, there were 3 participants with elevated fasting glucose at baseline. These 3 participants had normalization of their fasting glucose upon conclusion of the study, while there were no subjects who experienced hypoglycemia. All subjects reported stable serum albumin levels as documentation maintenance of proper nutritional balance.
Influence of a liquid nutrient concentrate on lipid
metabolism parameters in slightly overweight
individuals.Anatoly. G. Antoshechkin, M.D., Ph.D Scientific Director, Genext Research, Inc. Address correspondence to:Dr. Anatoly Anoshechkin, 1348 Harbor Lake Drive, Largo FL 33770, USAantoshechkin@genextresearch.comKey words: nutrient concentrate, obesity, weight managementAbstract A nutrient concentrate (manufactured by Nutrition Laboratories, Inc, of Florida, USA) was studied for its ability to influence on some clinical manifestations that are characteristic of changes in lipid metabolism. Such studies usually focus on individuals who are significantly overweight or obese. In this study, however, participants were
selected to form a group of individuals who were only slightly overweight, as indicated by an average body mass index (BMI) of 25.2.
35 healthy adults (26 females and 9 males) ingested the nutrient concentrate instead of breakfast for 36 days. They were instructed to make no other changes to their life styles. The participants made no modifications to their lunches or dinners but ate the food they normally would eat.
Measurements of blood pressure, concentration of glucose, insulin, two liver enzymes, total cholesterol, LDL, HDL, triglycerides and certain anthropometric measurements were carried out before and after the trial.
The most significant results of the trial are reduction of blood triglyceride levels–29.5% of the initial concentration. In individuals with increased blood insulin level (hyperinsulinemia), the average decrease of initial level was 22.0%. Blood sugar, insulin and cholesterol levels also decreased.
An unexpected result was a reduction in the activity of two liver enzymes (SGOT and SGPT). This indicates that the nutrient concentrate may have a systemic cleansing or detoxifying effect.
Body weight and body size measurements were also significantly reduced.
Introduction Few people, who are concerned about and pay attention to their body weight, realize that being overweight is manifestation of a disturbed lipid metabolism. In order to be able to control ones weight, it is necessary to influence the state of one’s lipid metabolism. The beginning of weight gain is usually accompanied by changes of lipid metabolism. An important manifestation of weight gain in an increase in the circumference of the waist. Harvard Medical School doctors recommend: “Rather than being an endorsement for getting fat, these findings may help us to pay attention to our waists, in addition to our weight. For most of us, the plain fact is that weight gain when we’re adults is an indication
that we are, indeed, getting fatter and therefore very likely at greater risk of suffering from a long list of diseases.It does get a little more complicated in older age. We lose muscle mass and bone density, so while we may weigh the same as we used to, or even less (and congratulate ourselves on being thin), we may actually be lugging around more fat tissue. So we need to keep an eye on our waist size, not just our weight, especially after about age 50. Waist size is a fairly accurate reflection of how much visceral fat we’ve accumulated in our abdomens. And visceral fat is the metabolically active form of fat that causes so much harm” (1).
In most studies dedicated to weight loss by dieting, participants are either significantly overweight or obese. Our study examines the beginning stage of weight gain and on the changes in lipid metabolism indicators that are reflected by blood analysis.The trial participants, dietary conditions and examinations
35 adult healthy individuals (26 females and 9 males) participated in the trial. They were only marginally overweight, with an average Body Mass Index of 25.2 (normal range is 18.5 - 24.9). In fact, the BMI of the participants bordered on normal. During the trial, which lasted 36 days, the participants took a liquid nutrient concentrate instead of eating breakfast. They were instructed to make no other changes to their life styles. The participants made no modifications to their lunches or dinners but ate the food they normally would eat. Following the trial, the participants were questioned regarding any side effects experienced during the trial. In each participant, the following measures were carried out before and after the trial: blood pressure, two liver enzymes SGOT and SGPT, determination in the blood the levels of following indicators of lipid metabolism: glucose, insulin, total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides and some anthropometric measurements.Results Measurements carried out before and after the trial showed the following average changes for the 35 participants:
WEIGHT REDUCTION
WEIGHT LOSS: 2.6 kg (4.0% reduction)
SIZE REDUCTIONS
NECK: 0.67 cm (1.9 % reduction)
CHEST: 1.89 cm (2.1% reduction)
WAIST: 4.4 cm (5.4% reduction)
BUTTOCKS: 2.4 cm (2.6% reduction)
RUMP: 2.99 cm (3.2% reduction)
BLOOD ANALYSIS
BLOOD PRESSURE REDUCTION: 2.06/1.09 (1.6% reduction)
TOTAL CHOLESTEROL REDUCTION: 9.51 mg/dL (4.7% reduction)
LDL REDUCTION: 4.15 mg/dL (2.0 % reduction)
HDL REDUCTION: 0.13 mg/dL (0.2% reduction)
TRIGLYCERIDES REDUCTION: 35.14 mg/dL (29.5% reduction)
BLOOD GLUCOSE REDUCTION: 11.5 mg/dL (12.1% reduction)
INSULIN REDUCTION: 1.06 IU/ml (12.6% reduction)
SGOT ACTIVITY DECREASE: 0.34 U/L (1.4 % decrease)
SGPT ACTIVITY DECREASE: 0.91 U/L (3.3% decrease)
The results obtained show that the intake of the nutrient concentrate during 36 days instead of a normal breakfast reduces the indicated parameters. The most significant changes concern weight, waist size and triglycerides.
It should be noted that the influence of the nutrient concentrate appears more effective in an individual with elevated blood concentration of triglycerides, total cholesterol, insulin and LDL before the trial since these readings in such individuals showed a greater reduction following the trial.
In five individuals with high level of triglycerides in blood (more 200 mg/dL, ranging from 230 to 315 mg/dL), the average reduction of the concentration of triglycerides was 163.4 mg/dL—60% of the average level of triglycerides before the trial in these five participants.
In 17 individuals with level of total cholesterol in the blood higher than 200 mg/dL, (ranging from 200 to 304 mg/dL), the average reduction of the initial level was 21.8 mg/dL —10% of the average level in these 17 persons before the trial. In three participants with high blood levels of LDL (more 160 mg/dL, ranging from 126 to 176 mg/dL), the average LDL reduction was 36 mg/dL—23% of the initial concentration of LDL before the trial.
In eight persons with increased blood insulin level (higher than 10 IU/ml, ranging from 10.5 to 20.3 UI/ml), the average decrease of the initial level was 3.2 IU/ml—a 22.0% of the initial level in these eight participants before the trial. In others participants concentration of insulin in the blood before the trial was on normal level and changed insignificantly.
An unexpected result was a reduction in the liver enzyme activity (1.4% reduction in SGOT and 3.3% reduction in SGPT), which indicates that the nutrient concentrate may have a systemic cleansing or detoxifying effect.
As evidenced by the questionnaire that the participants filled out following the program, no comments were made by the participants during the trial indicating side effects such as feeling week or hungry.
Discussion The participants in this trial do not belong to a typical overweight category. Their BMI was an average of 25.2, which is bordering on normal. Nevertheless, the intake of the nutrient concentrate during the trial demonstrates a significant influence on lipid metabolism and body weight.It is important to note that the nutrient concentrate was used only once per day instead of eating a usual breakfast.
The participants made no other modifications to the food intake during the rest of the day (lunch and dinner), nor did they in any other way change their life styles. It is not surprising that in patients with higher levels of triglycerides, total cholesterol, LDL and insulin the decrease of these blood components was more significant. The greater the lipid metabolism misbalance, the more remarkable can be the influence of an effective remedy to normalize metabolic balance.The effect of the nutrient concentrate could be explained by the following factors:
(1) A substitution of breakfast with a liquid nutrient concentrate reduces the intake of calories and cholesterol.
(2) Constituents in the nutrient concentrate may reduce appetite and therefore also decrease the intake of substances such as cholesterol.
(3) Some plant compounds in the nutrient concentrate may modulate expression of
genes involved in lipid metabolism. The ability of some herbal extracts to influence ongene expression has been demonstrated in experiments with cultivated human cells (2, 3).There is also recent evidence of gene-nutrient interactions with dietary fat (4).The results obtained in this trial point to a recommendation to control lipid
metabolism during the beginning stage of the development of gaining weight. Even witha BMI near 25, the use of a remedy that is capable of normalizing deviations from normin lipid metabolism, such as the nutrient concentrate used in this study, should berecommended.References (1) HealthBeat, Harvard Medical School, Issue May 25, 2010.
(2) Antoshechkin A, Olalde J, Magarici M. et al. Analysis of effects of the herbal
preparation Circulat on gene expression levels in cultured human fibroblasts.
Phytother Res. 2007; 21: 777-89.
(3) Antoshechkin A, Olalde J, Antoshechkina M et al. Influence of the plant extract
complex “AdMax” on global gene expression levels in cultured human fibroblasts.
J Diet Suppl. 2008; 5: 293-304.
(4) Phillips CM, Goumidi L, Bertais S et all. Gene-nutrient interactions with dietary
fat modulate the association between genetic variation of the ACSL1 gene and
metabolic syndrome. J Lipid Res. 2010 Feb 22 [Epub].
Medical Trial #2
Weight loss effects of a liquid nutrient concentrate:
A short clinical trial.Anatoly. G. Antoshechkin, M.D., Ph.D Scientific Director, Genext Research, Inc. Address correspondence to:Dr. Anatoly Anoshechkin, 1348 Harbor Lake Drive, Largo FL 33770, USAantoshechkin@genextresearch.comKey words: nutrient concentrate, obesity, weight managementAbstract 31 adult healthy individuals (26 females and 5 males) participated in a trial for the purpose of determining how a liquid nutrient concentrate (manufactured by Nutrition Laboratories, Inc. of Florida, USA) could be used to accomplish calorie restriction as part of a weight loss program. The participants used the liquid nutrient concentrate instead of breakfast and were put on a controlled diet consisting of 400 - 600 calories for lunch and 600 - 800 calories for dinner, with fresh fruit as snacks.The individuals chosen for the trial were significantly overweight, as evidenced byan average Body Mass Index of 37.2 (normal range 18.5-24.9).Measurements carried out before and after the trial showed the following average reductions for the participants:Weight loss: 3.4 kg
Waist size reduction: 7.0 cm
Hips size reduction: 5.9 cm
Chest size reduction: 6.5 cm
The results showed a clear tendency: The greater the weight of a participant, the more effective was the program.Interviewing the participants after the program revealed no complaints of side effects such as feeling weak or hungry. The Trial participants, dietary conditions and examinations 31 adult healthy individuals (26 females and 5 males) participated in a trial for the purpose of determining how a liquid nutrient concentrate could be used to accomplish calorie restriction as part of a weight loss program.The participants used the liquid nutrient concentrate instead of breakfast. Following breakfast, each was given two meals consisting of lean protein, vegetables and salad (400 to 600 calories for lunch and 600-800 calories for dinner). In addition, participants were given fresh fruit as snacks.The nutrient concentrate was during the afternoon to help reduce any side effectsfrom eating a low-calorie lunch and dinner. Foods excluded from the diet were dairy products, bread, rice, beans, potatoes,sugar and products made with sugar, fat and products made with added fat, beer andalcohol. The participants were also instructed to walk for half an hour per day as a form of exercise.The individuals chosen for the trial were significantly overweight, as evidenced by an average Body Mass Index of 37.2 (normal range 18.5-24.9). Measurements carried out before and after the trial showed the following average reductions for the thirty one participants:Weight loss: 3.4 kg
Waist size reduction: 7.0 cm
Hips size reduction: 5.9 cm
Chest size reduction: 6.5 cm
The results showed a clear tendency: The greater the weight of a participant, the more effective was the program. In the group of participants, two females had weights of more than 90 kg and BMI of 44.5 and 44.6. One lost 6.8 kg and another 4.3 kg. Two males in the group had initial weight more 100 kg with BMI 43.5 and 44.1. One lost 12.0kg and the other 9.1 kg. Interviewing the participants after the program revealed no complaints of sideeffects such as feeling weak or hungry.Discussion It is not surprising that the participants lost a significant amount of weight and body volume following this reduced calorie intake. What is significant is that the participants were able to remain on a reduced calorie intake for four weeks without experiencing side effects such as weakness or hunger.
A likely explanation of the effect of the nutrient concentrate is that the nutrient concentrate provides such a high level of overall nutrition that the participants experienced no further cravings for food. Constituents in the nutrient concentrate may also more directly reduce appetite and therefore make possible a reduction in calorie
intake.
Medical Trial #1
Effect of a short term nutrient concentrate program
on weight management, adipose tissue, cholesterol and
triglycerides in overweight adults.Michael J. Gonzalez, Jorge R. Miranda-Massari, Carlos M. Ricart, Heidi Ortega and Saisha M. Muñiz Alers InBio Med Projec, Medical Sciences Campus School of Public Health and Pharmacyand Dept. of Biology Cayey Campus, University of Puerto Rico.Address correspondence to: Dr. Michael J. Gonzalez School of Public Health, Dept HumanDevelopment, Nutrition Program, InBioMed Project, University of Puerto Rico, MedicalSciences Campus PO Box 365067 San Juan PR 00936-5067 email: mgonzalez@rcm.upr.edu.Key words: nutrient concentrate, obesity, weight managementAbstract A nutrient concentrate consisting of a liquid supplement (manufactured by Nutrition Laboratories, Inc. of Florida, USA) was studied to determine its safety and efficacy on weight/fat loss, cholesterol and triglycerides levels in thirty five overweight adults between ages 14-60. This open label trail measured total body weight, body fat percentage, waist circumference, hips (females), chest (females), abdomen (males), glucose, total cholesterol and triglycerides before and after one week on the concentrate. A group of thirteen subjects continued on the concentrate for one more week and anthropometric measures were obtained. Interestingly after only one week on the program the subjects experience a statistically significant (p < 0.05) weight reducing effect. This weight reduction was accompanied with a corresponding statistically significant (p < 0.05) decrease in body fat percentage.
In addition significant decrease in total cholesterol (p < 0.05) and triglycerides (p < 0.01) resulted. Also reduction in waist, hip and chest measurements were obtained. We conclude that the nutrient concentrate and protein supplement program studied herein is a safe and effective way to assist adults in weight, fat, cholesterol andtriglyceride reduction.Introduction The public health problem of obesity and unhealthy weight gain has grown considerably in the United States in recent years (1). We know this is a chronic disease that involves complex interactions among genetics, environmental, cultural and behavioral factors. A positive energy balance is required in order for weight gain to occur. In other words energy intake must exceed energy expenditure. Obesity is among the easiest medical conditions to diagnose, but most difficult to treat. The annual cost to society for obesity is estimated to be at nearly $ 100 billion/ year (2). Moreover, unhealthy weight gain is responsible for over 300,000 deaths/ year (3). Obesity has serious health consequences that have a disproportionate effect on minorities, women, children, the aged population and those in lower socioeconomic status. Obesity is associated with type II Diabetes mellitus, it increases the risk for Coronary Heart Disease, Osteoarthritis, Cancer and Stroke (4). We embarked in this study to evaluate the safety and efficacy of this short term dietary supplement program for weight/ fat loss. Methods
The target subjects included overweight and obese (10% and above average body weight with a body mass index (BMI) over 25. The study sample consisted of 35 experimental subjects for the first week and 13 follow up experimental subjects for the second week those consisted of 22 females and 13 males between the ages of 14-60 in the first group and 13 subjects that decided to continue the diet for one more week (10 females and 3 males) in the second group. All participants completed a general health questionnaire and anthropological measures such as body weight, height, percent body fat, waist, hip, and chest measurements. Blood tests (fasting) such as CBC and SMA 20 were taken at the beginning of the study and a week after treatment. Eligible volunteers meeting all inclusion criteria who consented were included in the study and provided with the supplements. The participants received a liquid nutrient concentrate to be utilized for a week as part of the experimental program. This product consisted of a blend of juices including aloe and pomegranate and mixture of botanical tea extracts that included Ginseng, Green tea, Gymmena silvestre, Garcinia cambodia, Yerba mate, Cascara sagrada, plus a mixture of additional vitamins and minerals, (B complex, Vitamin C and Chromium). For the purpose of controlling the calorie intake during the study and ensure that the participants a balanced diet, they also received a protein shake consisting of 16g of protein, 1g of fat, 1g of sugar, 2g of fiber and an enzyme mixture per serving. The participants were recommended to take the protein shake twice a day with skim milk as breakfast and lunch. The participants were encouraged to do some form of daily exercise, such as a half hour walk. They were otherwise instructed to continue their normal lifestyle with no other weight reduction regime other than the experimental program. Compliance with all study related procedures were strictly monitored. All subjects dispensed with enough concentrate and protein for a week of use.
Statistical Analysis
The data was analyzed using the statistical package SPSS version 12. A Kolmogorov-Smirnoff goodness of fit test was performed on all variables in the experimental group to test the null hypothesis that the data came from a normally distributed population. The results accepted the null hypothesis for all variables (p < 0.05). Next a parametric paired-sample t-test was carried out to determine that there is no significant difference between the mean of the initial measurements (i.e. before treatment) and the mean of the subsequent measurements (i.e posttreatment). This test was performed for each variable included in the experimental group (treated with the dietary program). All results rejected the null hypothesis and the means were significantly different (p< 0.05). Also an analysis of variance was performed between the three measurements resulting in a significant difference (p < 0.05 ) among the three measurements. Finally, a Pearson coefficient was calculated to test the degree of correlation in the change detected between the pre and post-treatments. All results showed a significant coefficient (p< 0.05) consistent with the changes observed experimentally. Results All measurements reported on the 36 subjects were taken twice during the study (at the beginning and at 7 days of dietary treatment) another measurements were taken on the 13 subjects that continued treatment for one more week. All subjects served as their own controls.
Total body weight: The average weight loss was 7.5 lb. ± 2.30 during one week of dietary treatment. The mean ± SE per body weight at the beginning of the study was 198.34 lb. ± 6.68 and at the end of the week was 190.89 lb. ± 6.21. This difference was found to be statistically significant (p < 0.05). In the 13 subjects that continued the dietary program for 1 more week their mean body weight after the treatment was 180.52 lb. ± 5.51 (their mean body weight before second treatment was 188.55 lb. ± 4.87)
Body Fat Percentage: The average % fat loss was 3.02% ± 0.99. The mean ± SE for body fat % at the beginning of the study was 39.61% ± 1.07 and at the end was 36.59% ± 1.01. This difference was found to be significant (p < 0.05). In the subjects that extended their treatment for one more week the mean body fat percentage was 33.01% ± 0.98 (The man body fat percentage before the second treatment was 36.20% ± 1.01)
Waist measurement: The average waist measurement loss was 2.32 in ± 0.81. The waist measurement at the beginning was 40.046 in ± 1.03 and at the end 38.14 in ±0.99. This difference was found to be significant (p < 0.05). The subjects that followed treatment for one more week the mean waist measurement was 36.25 in ± 1.01 (Their mean measurement before the second treatment was 38.29 in ± 1.01).
Hips measurement: This measurement was only taken on females. The average hip measurement loss was 2.80 in ± 1.05. The mean hip measurement at the beginning was 44.89 in ± 1.07 and at the end of the first week 42.09 in ± 1.00. In the subjects that had an extra week of the treatment the mean was 40.20 in ± 0.99. These differences were found to be statistically significant (p<0.05).
Chest measurement: This measurement was also taken just on female subjects. The average chest measurement at the beginning of the study was 42.04 in ± 1.08 and at the end 40.11 in ± 1.07. In the subjects that furthered their treatment for a week the mean was 37.98 in ± 1.05.These differences were statistically significant (p<0.05).
Abdomen measurement: The measurement was done only on male subjects. The average loss on abdomen measurement was 2.45 in ± 0.99. The abdomen measurement at the beginning of the study was 44.00 in ± 1.02 and at the end 41.66 in ± 0.88. For the group that had an extra week of treatment the average measurement was 38.42 in ± 0.90. These differences were found to be statistically significant.
Glucose: Glucose measurement at the beginning of the study was 84.99 mg/dL ± 1.47 and at the end 81.82 mg/dL ± 1.43. For the group that had an extra week of treatment was 80.75 ± 1.45. Here a tendency toward reduction was attained but only statistical difference was obtained for the pretreatment vs. post treatment values (p<0.05).
Total cholesterol: The average loss of total cholesterol was 5 mg/dL ± 5.25. The total cholesterol at the beginning was 186.32mg/dL ± 7.85 and at the end 181.32 mg/dL ± 0.81. For the group that had an extra week of treatment was 180.37 mg/dL ± 4.55. These differences did not result in a statistical difference. Nevertheless, when we separate the subjects that had total cholesterol over 200 from the rest of the group (14 subjects) their total cholesterol at the beginning was 237.5 mg/ dL ± 5.51 and at the end it was 211.05 mg/dL ± 5.25 which resulted in
a statistically significant difference (p<0.01). Triglycerides: The average loss in triglyceride value was 22.31 mg/dL ± 7.01. The triglyceride level at the beginning of the study was 115.25 mg/dL ± 9.52 and the end was 92.94 mg/dL ± 7.09. The triglyceride level for the subject that had an extra week of treatment was 80.37 mg/dL ±6.99. These differences had a statistical significance (p<0.05).
Discussion
This clinical investigation utilizing a short term nutrient concentrate and protein supplement program for weight/fat loss was undertaken because to date data available on safety and efficacy of such programs are lacking. Most short term “fad” diets may produce weight loss by means of solely water loss with no measurable fat loss. This research was an open label experimental clinical trial in which subjects served as theirown control for a period of one week and a subset for another additional week. The primary aim of the research was to test for the program safety and the secondary aim was to test for effectiveness by identifying any changes in total body weight, body fat percentage, waist, hips, chest measurements, as well as glucose, total cholesterol and triglycerides. In relation to total body weight, we achieved a significant reduction in only seven days on the program. Moreover, body fat percentage was significantly reduced during that short period. These results demonstrated in part that weight loss was due to fat loss instead of only water content or muscle loss. Waist, hips, abdomen, and chest measurements were also significantly reduced. These results are of great importance to the subjects since the loss of fat inches is what they perceive as success rather than just the loss of body weight. Also 90% of the subjects reported reduce appetite and more energy while in the program. There was a tendency of reduction of fasting blood glucose but did not reach statistical significance although we should mention that fasting blood glucose in the subjects at the start of the study were within normal ranges. The only statistical difference was obtained when comparing pre-treatment vs. post-treatment. We should state this difference was within normal ranges as stated earlier and seems to lack any physiological significance or to have any biological impact. Nevertheless, it would be interesting to do a similar study with subjects having glucose/ insulin problems (syndrome X, diabetes, etc.). In relation to total cholesterol, there was a tendency toward reduction that did not reach statistical significance. Although it should be pointed out that total cholesterol value for this sample population was within normal ranges. But when we separate the subjects with total cholesterol values of over 200 their mean total cholesterol value was 237.5 mg/dl ± 5.51 and at one week after treatment lowered to 211.05 mg/dl ± 5.25 which resulted in a statistically significant difference (p<0.01). In relation to triglycerides these reduced significantly after one week on the dietary treatment program. This dietary intervention program had no negative side effects, compliance was excellent (90%). A point of discussion is how can this short term program be effective. We believe is due to metabolic correction and systemic detoxification. Metabolic correction refers to a combination nutrients that provides the necessary building blocks or cofactors to improve enzyme function. Thus, correcting and optimizing metabolism. These nutrients seem to correct subclinical deficiencies and metabolic imbalances probably due to a faulty diet consisting of empty calories that lack the necessary nutrients and fiber. Also a faulty diet contains additives, processed material that may provide a toxic environment that may prevent or make difficult, the physiological changes necessary and metabolic alignment to achieve weight/ fat loss and at the same time assist normal physiological functions. The dietary supplement program presented herein resulted in a safe and effective short term way to achieve weight loss, reduce body fat and improve lipid profile. Acknowledgements
The authors wish to thank our research assistant Ms. Enid Bauza for her valuable help in this research study. References
(1) Gonzalez MJ, Miranda-Massari JR, Ricart CM. Effect of a dietary supplementcombination on weight management, adipose tissue, cholesterol and triglyceride in obesesubjects. PR Health Sci J 2004,23:121-124. (2) Wellman NS, Friedberg B. Causes and consequences of adult obesity: health, social, andeconomic impact in the United States. Asia Pac J Clin Nutr 2002,(58):5701-709. (3) Stern CJ, Colditz GA. The epidemic of obesity. J Clin Endocrinol Metab 2004,89:2522-2525. (4) World Health Organization: Obesity: Prevention and managing the global epidemic.Report of Who consultation on obesity. Geneva; World Health Organization 1997 About the Authors
Dr. Michael J. Gonzalez is a professor at the Medical Sciences Campus of the University of Puerto Rico. He earned a Bachelor degree in biology and chemistry (Catholic University), a Masters in Cellular Biology and Biophysics (Nova University) and another Masters in Nutrition and Public Health (University of P.R.). He also has a Doctorate in Health Sciences (Lafayette University) and another Doctorate in Nutritional Medicine (John F. Kennedy University) and a third Doctorate on Nutritional Biochemistry and Cancer Biology (Michigan State University). He completed a Postdoctoral Fellowship in Geriatrics in the School of Medicine of the University of Puerto Rico. Dr. Gonzalez is a Fellow of the American College of Nutrition and a Fellow of the American Nutritional Medical Association. He is author of over a 100 scientific publications. He is a member of the Editorial Board of several scientific journals such as Biomedicina, the Journal of Orthomolecular Medicine and Alternative Medicine Reviews. He has also been a consultant for several companies and responsible of designing formulations of supplements and pharmaceutical products. He is also a consultant for The Center for the Improvement of Human Functioning. He has obtained various research awards for his work on nutrition and cancer. He is currently Director of RECNAC II project and research director of the InBioMed initiative. Dr. Jorge R. Miranda-Massari is a professor at the Medical Sciences Campus of the University of Puerto Rico and a registered Pharmacist. He earned two bachelor degrees one in Science and another in Pharmacy (University of P.R.). He also earned a doctorate degree in Pharmacy (Philadelphia College of Pharmacy and Science) and a postdoctoral Fellowship in Clinical Pharmacokinetics (University of North Carolina). He completed postdoctoral training in Pharmaceutical Care in Nephrology (University of Pittsburgh) and another one in Clinical Anticoagulation (Medical College of Virginia). He is author of numerous scientific publications. Dr. Miranda is a consultant in the area of Clinical Pharmacokinetics of the prestigious Center for the Improvement for the Human Functioning in Wichita, Kansas. He is also the Director the Education Branch of the innovative InBioMed (Institute of Biochemical Medicine) Project and Clinical Research Director of the RECNAC II Project. Dr. Carlos Ricart is an associate professor at the Biology Department of the University of Puerto Rico Cayey Campus. He earned a bachelor degree in Biology at the Catholic University, a Masters in Field Ecology with a minor in statistics, from the University of Colorado at Boulder. He later earned a doctorate in the same field, also at University of Colorado. He is currently the Director of Statistics of the InBioMed (Institute of Biochemical Medicine) Project.
|
|
|
