Effects of a Glucagon-like Peptide-1 (GLP-1) Booster™ on Blood Glucose, HbA1c, Insulin, Glucagon, GLP-1, GIP, and Amylin 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
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- fasting blood HbA1c 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 In prior study, GB was clinically shown to reduce blood sugar level, increase GLP-1 production, and help body fat loss. The purpose of this RCT study is to further assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula vs placebo, in the hope of confirming the efficacy and safety of GB.
SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, this study is a randomized controlled clinical trial for a total of 26 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints (week 0, 13 and 26).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 26-week study.
- •Caffeine drinking volunteers must maintain their caffeine intake consistently throughout the course of the 26-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
- 未提供
结局指标
主要结局
fasting blood HbA1c level
时间窗: 26 weeks
lab
fasting blood glucose level
时间窗: 26 weeks
lab
fasting blood Amylin level
时间窗: 26 weeks
lab
fasting blood insulin level
时间窗: 26 weeks
lab
fasting blood GLP-1 level
时间窗: 26 week
lab
fasting blood glucagon level
时间窗: 26 weeks
lab
fasting blood GIP level
时间窗: 26 weeks
lab
fasting body weight
时间窗: 26 weeks
measurement
body fat mass
时间窗: 26 week
measurement
waist hip ratio
时间窗: 26 weeks
measurement
次要结局
- satiety score(26 weeks)
- resting metabolic rate(26 weeks)
- Blood pressure(26 weeks)
- Heart rate(26 weeks)
- Energy level(26 weeks)
- satiety score(26 weeks)
- resting metabolic rate(26 weeks)
- Blood pressure(26 weeks)
- Heart rate(26 weeks)
- Energy level(26 weeks)
研究者
Lawry Han
Principal Investigator
Alpine Biotech LLC