Study

Weight-loss Research Study Summation

A Medical University Research Study done on thirty-five overweight adults taking the
NuLean Wellness Weight-Loss Cleanse revealed that after seven days:

• The average person lost 7.5 pounds.

• The average combined total inches lost per person (waist, chest, hips abdomen) was 7.63
inches.

• Average glucose measurement per person dropped by 3.7%

• Reduction in body fat was 3.02%.

• Average total cholesterol per person dropped by 5%.

• The average loss in triglycerides per person was 19.3%.

Director of the study, Michael J. Gonzalez, M.D., stated:
“This dietary intervention program had no negative side effects, compliance was excellent
(90%). A point of discussion is how can this short-term program can be effective. We
believe it is due to metabolic correction and systemic detoxification. Metabolic-correction
caused by the combination of supplements in the diet that provide the necessary building
blocks to improve enzyme function. Thus, correcting and optimizing metabolism. "These
nutrients seem to correct sub-clinical deficiencies and metabolic imbalances probably due
to a faulty diet consisting of empty calories that lack 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 to
achieve weight/ fat loss and at the same time assist normal physiological functions. The
dietary supplement program presented herein resulted as a safe and effective short-term
way to achieve weight loss, reduce body fat, and improve lipid profile.”

NuLean Wellness Weight-Loss Cleanse Results

Effect of a short term dietary supplement combination program on weight management,
adipose tissue, cholesterol and triglycerides in overweight adults

Michael J. Gonzalez,1 Jorge R. Miranda-Massari, 1 Carlos M. Ricart,2 Heidi Ortega,1 and
Saisha M. Muññiz Alers1

InBio Med Project Medical Sciences Campus School of Public Health and Pharmacy and
Dept. of Biology Cayey Campus, UPR

The study was funded by a grant provided by Nulab inc. Fl. USA

Key words: dietary supplement, obesity, weight management

Abstract

A dietary supplement combination program consisting of liquid supplement and a protein
shake 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 dietary program. A group of thirteen subjects continued on the
dietary program for one more week and anthropometric measures were obtained.
Interestingly after only one week on the dietary supplement program the subjects
experience a statistically significant (p 20.05) weight reducing effect. This weight reduction
was accompanied with a corresponding statistically significant (p < 20.05) decrease in
body fat percentage. In addition significant decrease in total cholesterol (p < 20.05) and
triglycerides (p < 20.01) resulted. Also reduction in waist, hip and chest measurements
were obtained. We conclude that the dietary supplement combination program studied
herein is a safe and effective way to assist adults in weight, fat, cholesterol and triglyceride
reduction.

Introduction

The public health problem of obesity and unhealthy weight gain has grown considerably in
the United States and Puerto Rico in recent years (1). We know this is a chronic disease
that involves complex interactions among genetics, environmental, cultural and behavioral
factors. 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. All volunteers living in Ponce, Puerto Rico. 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 recovered two dietary
supplement to be utilized for a week as part of the experimental program. They received a
protein shake mix and a liquid supplement to be used in the following manner: a protein
shake mix consisting of 16g of protein, 1g of fat, 1g of sugar, 2g of fiber and an enzyme
mixture. This shake is taken two times a day to replace breakfast and lunch (a scoop 24 g
is added to water or skim milk. The second supplement is a liquid juice, consisted of a
mixture of juices with aloe and pomegranate and a mixture of botanical extracts with
Ginseng, green tea, guarana, Gymmena silvestre, Garcienia cambodia, Yerba mate, Cascara
sagrada, and citrus aurantium with a mixture of additional vitamins and minerals, (B
complex, vitamin C and chromium). The participants were encouraged 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 supplement 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 post-treatment). 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 < 20.05). 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 th 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 < 20.05). 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 just 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 dietary supplement program for weight/fat
loss was undertaken because to date data available on safety and efficacy of short term
dietary supplement programs such as these are lacking. Most short term “fad” diets may
produce weight loss by means of solely water loss with no fat loss.

This research was an open label experimental clinical trial in which subjects served as their
own control for a period of one week and a subset for another additional week. The
primary aim of the research was to test for 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 weight loss was due to fat loss and not only water
content or muscle. 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 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 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 of 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 the
combination of supplement regime that provides the necessary building blocks 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 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 to achieve weight/ fat loss and at the
same time assist normal physiological functions. The dietary supplement program
presented herein resulted as 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 supplement combination on weight
management, adipose tissue, cholesterol and triglyceride in obese subjects. PR Health Sci J 2004,23:121-124.

2. Wellman NS, Friedberg B. Causes and consequences of adult obesity: health, social, and economic 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