Clinical trial NCT01634646: Observational Study of Lyzme5 Impact on Cholesterol and Body Weight in Man
Official title: A Placebo-Controlled Pilot Study to Observe the Impact Lyzme5 Has on Cholesterol and Body Weight in Man
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight
Elevated Cholesterol
Keywords: Observational study
Lead sponsor: All American Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: All American Pharmaceutical
First posted: 2012-07-06
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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 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.

Primary outcomes:
measure: Weight loss
timeFrame: 60 days post initiation
Secondary outcomes:
measure: Cholesterol reduction
timeFrame: 60 days post initiation
Other outcomes:
Locations:
city: Billings
country: United States
facility: All American Pharmaceutical and Natural Foods Corporation
state: Montana
Study officials:
affiliation: All American Pharmaceutical
name: Jeff Golini
role: PRINCIPAL_INVESTIGATOR
References: