Observational Study of Lyzme5 Impact on Cholesterol and Body Weight 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.

Inclusion Criteria:

- At least 21 years of age or older;

- Able to read, understanding, and signing a consent form;

- Not pregnant or breast feeding (female only);

- Have normal bio-markers for liver and kidney function (determined by blood test);

- Being at least 15 lbs over your ideal weight as defined by the Body Mass Index [BMI]
chart;

- Have a total cholesterol level of or in excess of 200 mg/dl (determined by blood
test);

- Not using any illegal substances, including marijuana (medicinal or otherwise);

- Not using any "recreational drugs"

- Weighing less than 300 lbs

Exclusion Criteria:

- Under 21 years of age;

- Mentally impaired;

- Pregnant or breast feeding;

- A diabetic;

- Having digestion problems;

- Problems with kidneys, heart, or liver;

- Having, or have had cancer;

- Taking a prescription;

- Weight of 300 lbs or over;

- Total cholesterol under 200 mg/dl;

- Using "recreational" drugs.