Overweight Clinical Trial
Official title:
A Placebo-Controlled Pilot Study to Observe the Impact Lyzme5 Has on Cholesterol and Body Weight in Man
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.
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Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)
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