Observational Study of Lyzme5 Impact on Cholesterol and Body Weight in Man

Jeff Golini

Status: Terminated

Conditions: Elevated Cholesterol; Overweight

Treatments: Dietary Supplement: Lyzme5

Study type: Interventional

Funder types: Industry

Identifiers

NCT01634646

Lyzme5-IRB26715/1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

19 participants in 1 patient group, including a placebo group

Overweight, elevated total cholesterol

Placebo Comparator group

Description:

All individuates enrolled in this study are at least 15 lbs over their ideal weight as described on a BMI chart. Each individual must also have a total cholesterol of at least 200 mg/dl, or higher.

Treatment:

Dietary Supplement: Lyzme5