Observational Study of Lyzme5 Impact on Cholesterol and Body Weight in Man (Lyzme5)
|ClinicalTrials.gov Identifier: NCT01634646|
Recruitment Status : Terminated (Unable to recruit sufficient local qualifying volunteers for study.)
First Posted : July 6, 2012
Last Update Posted : July 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Overweight Elevated Cholesterol||Dietary Supplement: Lyzme5||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Placebo-Controlled Pilot Study to Observe the Impact Lyzme5 Has on Cholesterol and Body Weight in Man|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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.).
A single serving of the assigned material (Lyzme5 or the placebo) each day, 20 minutes before breakfast;
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.
- Weight loss [ Time Frame: 60 days post initiation ]Volunteers will be weighed at the beginning and end of their 60 day participation. Weight loss (or gain) will be assessed.
- Cholesterol reduction [ Time Frame: 60 days post initiation ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634646
|United States, Montana|
|All American Pharmaceutical and Natural Foods Corporation|
|Billings, Montana, United States, 59105|
|Principal Investigator:||Jeff Golini||All American Pharmaceutical|