Observational Study of Lyzme5 Impact on Cholesterol and Body Weight in Man
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.
|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|
- 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.
- 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.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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.
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.
|Contact: Jeff Golini||(406) firstname.lastname@example.org|
|Contact: Diane Black||(406) 245-5793 ext 217||DianeB@allamericanpharmaceutical.com|
|United States, Montana|
|All American Pharmaceutical and Natural Foods Corporation||Recruiting|
|Billings, Montana, United States, 59105|
|Contact: Jeff Golini 406-245-5793 JeffG@allamericanpharmaceutical.com|
|Contact: Diane Black (406) 245-5793 ext 217 DianeB@allamericanpharmaceutical.com|
|Principal Investigator: Jeff Golini|
|Principal Investigator:||Jeff Golini||All American Pharmaceutical|