This observational placebo-controlled pilot study is intended to document whether or not Lyzme5, an over-the-counter (OTC) proprietary nutritional supplement product can positively impact, (a) weight and, (b) cholesterol levels in man.
Lyzme5 is a nutritional supplement, according to the Dietary Supplement Health and Education Act (DSHEA) of 1994. It is composed of B Vitamins along with a non-essential amino acid. The individual components of this supplement are individually Generally Recognized as Safe (have GRAS status). The manufacturer's objective was to create a nutritional supplement that would have the potential to positively impact body weight, and possibly one or more lipid value (i.e., total cholesterol, LDL, triglycerides)as well, in overweight individuals who may also have minimally elevated cholesterol levels. This observational clinical study will seek to recruit 100 volunteers in order to observe whether or not the weight-loss potential of Lyzme5, previously observed earlier in three volunteers, can be duplicated within a larger group. The second objective is to establish whether or not Lyzme5 can positively impact cholesterol levels in man.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
DOUBLE
Enrollment
19
Dietary Supplement (or placebo): Lyzme5 (or the placebo) is to be mixed with 4 fluid ounces of a sugar free flavored drink (example: kool aid, crystal light, flavored tea drink, etc.). Week one: A single serving of the assigned material (Lyzme5 or the placebo) each day, 20 minutes before breakfast; Week two: Two (2) servings of the assigned material each day - the first, 20 minutes before breakfast and the second 20 minutes before the noon meal; Week three through the end of the study: Three (3) servings per day of the assigned material - the first, 20 minutes before breakfast, the second, 20 minutes before the noon meal, and the third, 20 minutes before the last meal of the day.
All American Pharmaceutical and Natural Foods Corporation
Billings, Montana, United States
Weight loss
Volunteers will be weighed at the beginning and end of their 60 day participation. Weight loss (or gain) will be assessed.
Time frame: 60 days post initiation
Cholesterol reduction
The following will be assessed at enrollment, after 30 days, and at the conclusion of the volunteer's 60 day participation: Total cholesterol, HDL, LDL, and triglyceride levels.
Time frame: 60 days post initiation
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