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

NCT01634646 | Terminated DMC

• 1 other identifier: Lyzme5-IRB26715/1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Elevated Cholesterol

Keywords

Observational study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cholesterol reduction

  60 days post initiation

Study Arms (1)

Overweight, elevated total cholesterol

PLACEBO COMPARATOR

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

Interventions

Lyzme5 DIETARY_SUPPLEMENT

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.

Overweight, elevated total cholesterol

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeff Golini: lead
• All American Pharmaceutical: collaborator

Study Sites (1)

All American Pharmaceutical and Natural Foods Corporation

Billings, Montana, 59105, United States

Location

MeSH Terms

Conditions

Overweight; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Study Officials

• Jeff Golini

  All American Pharmaceutical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President and Executive Scientist

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

US (1)