Placebo Controlled Pilot Trial to Determine the Effect of Metabolic Rheostat™ and Butyrate Ultra on Hemoglobin A1C and Blood Glucose Levels in Patients With Pre-diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra
研究概览
简要总结
The aim of this study is to examine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with prediabetes. In addition, the study also aims to look at the effect of Metabolic Rheostat™ and Butyrate Ultra on weight, HgbA1c, fasting glucose, cholesterol, triglycerides, inflammation markers, and hormones.
详细描述
This is a double blinded, pilot placebo-controlled trial of two interventions compared to placebo to determine the effects individually of Metabolic Rheostat™ and Butyrate Ultra daily consumption for 8 weeks on glucose homeostasis in subjects with prediabetes. The entire study will last 10 weeks including screen. The study will include 20 subjects with prediabetes treated with Metabolic Rheostat™; 20 subjects with prediabetes treated with Butyrate Ultra and 20 subjects with prediabetes treated with placebo. Participants will take 6 capsules daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects with pre-diabetes.
- •Age> 18 years
- •Ability to understand and the willingness to sign a written informed consent.
- •Willing and able to comply with trial protocol and follow-up.
排除标准
- •Current use of any other investigational agent.
- •Current use of any agent for treatment of diabetes.
- •History of adverse effects, intolerance, or allergic reactions attributed to any medications.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Abnormal blood analysis for complete blood count (CBC), hepatic and renal injury tests.
结局指标
主要结局
Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra
时间窗: 2 hours
Determine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with pre-diabetes.
次要结局
- Metabolic impact of Metabolic Rheostat and Butyrate Ultra(8 weeks)
- Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings(8 weeks)
研究者
Zhaoping Li
Chief / Professor of Medicine
University of California, Los Angeles