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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Placebo-Controlled Pilot Study to Observe the Impact Lyzme5 Has on Cholesterol and Body Weight in Man

Conditions
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Overweight, Elevated Cholesterol

Intervention / Treatment
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* Dietary Supplement: Lyzme5


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Overweight, elevated total cholesterol<br>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. | Dietary Supplement: Lyzme5<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Volunteers will be weighed at the beginning and end of their 60 day participation. Weight loss (or gain) will be assessed. | 60 days post initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 60 days post initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Observational study