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

This study has been terminated.
(Unable to recruit sufficient local qualifying volunteers for study.)
Sponsor:
Collaborator:
All American Pharmaceutical
Information provided by (Responsible Party):
Jeff Golini, All American Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01634646
First received: July 3, 2012
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Overweight
Elevated Cholesterol
Dietary Supplement: Lyzme5

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Placebo-Controlled Pilot Study to Observe the Impact Lyzme5 Has on Cholesterol and Body Weight in Man

Resource links provided by NLM:


Further study details as provided by All American Pharmaceutical:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 60 days post initiation ] [ Designated as safety issue: No ]
    Volunteers will be weighed at the beginning and end of their 60 day participation. Weight loss (or gain) will be assessed.


Secondary Outcome Measures:
  • Cholesterol reduction [ Time Frame: 60 days post initiation ] [ Designated as safety issue: No ]
    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.


Enrollment: 19
Study Start Date: May 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Overweight, elevated total cholesterol
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

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.


Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01634646

Locations
United States, Montana
All American Pharmaceutical and Natural Foods Corporation
Billings, Montana, United States, 59105
Sponsors and Collaborators
Jeff Golini
All American Pharmaceutical
Investigators
Principal Investigator: Jeff Golini All American Pharmaceutical
  More Information

No publications provided

Responsible Party: Jeff Golini, President and Executive Scientist, All American Pharmaceutical
ClinicalTrials.gov Identifier: NCT01634646     History of Changes
Other Study ID Numbers: Lyzme5-IRB26715/1
Study First Received: July 3, 2012
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by All American Pharmaceutical:
Observational study

Additional relevant MeSH terms:
Body Weight
Hypercholesterolemia
Overweight
Signs and Symptoms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 28, 2014