Le Patch Clinical Study

Submitted by: Marvin Kaplan, Ph.D.

The purpose of this research was to determine the average amount of body weight loss over a sixty day period for both men and women who would apply one Le Patch daily to their bodies for the duration of the test. The group was unsupervised and only their beginning weight and ending weight were recorded. The individual weights were recorded by the participants every 7-days for the first 30 days, then every 10-days for the next 30 days.

Selection Criteria
100 male and female subjects between the ages of 19 - 67 years of age, whose body weight was between 17 - 163 pounds in access of normal as determined from the Metropolitan Life Insurance Co. body weight charts, were admitted to the study.

The one basic requirement and true common denominator was that the participants were over their desired weight. The participants represented a cross section of society with a representative number from all occupation groups (laborer, blue collar, white collar and executive) including homemakers (working and non-working mothers).

Demographics

Participant Ethnicity	Participant Gender
73% White 20% African American 7% Hispanic	62 Women 38 Men
100%	100 People

All participants had attested to trying many and varied diets and weightloss programs over a period of one or more years. Approximately 25% expressed skepticism about the effectiveness of a "patch" to lose weight.

All admitted that they lacked the motivation and will power to follow through even with most structured weight loss programs in the past. They subconsciously forgot to do or to take what they were supposed to or procrastinated to the point of rendering their programs obsolete.

It is significant to note that the motivation to lose weight was so high that all 100 people participated for the full 60 day test.

The participants reported that after the first few days of wearing the patch on the wrist or other highly visible area, the daily routine was established and they began to wear the patch on less conspicuous areas.

Effectiveness
At the first postbaseline evaluation (after 7 days of wearing the patch) the overall mean weight loss for the participants was 2.69% of the baseline. Each subsequent postbaseline evaluation reported by the participants produced a constant decrease in their baseline weight. At the end of 30 days the mean postbaseline weight loss for the participants was 7.85% body weight. At the conclusion of the 60-day period the investigator reports a mean weight loss of all participants of 13.02% of baseline average weight.

Average Weightloss Totals
The following are the results in percentage (%) of average body weightloss for both men and women for 60 days.

Time Elapsed	Women	Men
7 Days 14 Days 21 Days 30 Days 40 Days 50 Days 60 Days	3.04% 4.87% 6.35% 7.92% 9.66% 11.71% 13.59%	2.35% 4.18% 5.92% 7.79% 8.95% 11.54% 12.46%
Age Range (In Years) Average Age Overweight Range in Pounds Average Overweight	19 to 64 37 17 to 163 54 Lbs.	22 to 67 35 21 to 148 52 Lbs.

Safety
Side effects experienced by only 2 participants consisted of mild skin irritation when wearing the patch on the inside of the upper arm. The same subjects did not repeat this side effect after alternating the placement of the patch. No other side effects were reported.

Conclusion
The efficacy of the Fucus Vesiculosus, Guarana Extract, Garcinia Extract and Menthol patch was 100%. All participants lost weight while wearing the patch for the full 60 days. Those with the least amount of body weight to lose continued to wear the patch to maintain their desired body weight. The most significant weight loss was 71 pounds by one highly motivated individual who followed the "letter of the plan", ate properly, consumed eight 8oz. glasses of water per day, walked daily, and participated in structured and supervised exercise program.