Effect of a Glucagon Like Peptide 1 (GLP1) Booster on Blood Glucose, HbA1c, Insulin, and GLP1 Levels, Body Weight and Body Fat in Overweight Adult Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- blood insulin level
研究概览
简要总结
BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.
PURPOSE The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.
SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers must be over the age of
- •Volunteers cannot be smokers.
- •Volunteers cannot be currently taking a dietary supplement or prescription for weight loss.
- •Exercising volunteers must maintain their regimen consistently throughout the course of the 12-week study.
- •Caffeine drinking volunteers must maintain their caffeine intake consistently throughout the course of the 12-week study.
- •Volunteers need to be overweight but not obese, as defined by having a BMI between 25.0 and 29.9
排除标准
- •Female volunteers who are pregnant or planning to become pregnant within the next three months.
- •Volunteers who are taking any stimulant medications (e.g. Adderall, Adzenys, Dexedrine, Ritalin, Methylphenidate, etc).
结局指标
主要结局
blood insulin level
时间窗: 12 week
blood HbA1c level
时间窗: 12 week
body fat index
时间窗: 12 week
blood glucose level
时间窗: 12 week
blood GLP1 level
时间窗: 12 week
blood cholesterol level
时间窗: 12 week
body weight
时间窗: 12 week
waist hip ratio
时间窗: 12 week
body fat mass
时间窗: 12 week
body lean mass
时间窗: 12 week
body mass index
时间窗: 12 week
次要结局
- Resting metabolic rate(12 week)
- Blood pressure(12 week)
- Heart rate(12 week)
- Satiety score(12 week)