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

Overweight Clinical Trial

— Lyzme5  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01634646
• Other study ID #: Lyzme5-IRB26715/1
• Status: Terminated
• Phase: N/A
• First received: July 3, 2012
• Last updated: July 12, 2013
• Start date: May 2012
• Est. completion date: January 2013

Study information

• Verified date: July 2013
• Source: All American Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Body Weight
• Elevated Cholesterol
• Hypercholesterolemia
• Overweight

Intervention

Dietary Supplement:
• Lyzme5
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.

Locations

Country	Name	City	State
United States	All American Pharmaceutical and Natural Foods Corporation	Billings	Montana

Sponsors (2)

Lead Sponsor	Collaborator
Jeff Golini	All American Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No