A Placebo-Controlled Pilot Study to Observe the Impact Lyzme5 Has on Cholesterol and Body Weight in Man
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Weight loss
时间窗: 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.
次要结局
- Cholesterol reduction(60 days post initiation)
研究者
Jeff Golini
President and Executive Scientist
All American Pharmaceutical