Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Dihydroberberine 100
研究概览
简要总结
The purpose of this study is to determine the bioavailability of berberine and dihydroberberine and their impact on changes in plasma concentrations of glucose and insulin.
详细描述
Once determined eligible and provided consent, participants will be assigned in a randomized, double-blind, placebo-controlled, crossover fashion. Eligible study participants will complete one of four testing conditions. For each testing condition, study participants will arrive in the lab after observing an overnight fast. Upon arrival, participants will donate the first of six venous blood samples. Follow-up blood samples will be collected at 20, 40, 60, 90, and 120 minutes. All collected samples will be collected into two, 4mL EDTA tubes and have aliquots of 600 ul of plasma isolated and frozen at -80 degrees celsius. Collected plasma will be analyzed for changes in berberine, glucose, and insulin. Participants will observe a minimum of 72 hours washout between conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All participants will be between the ages of 18-45 years.
- •Participants will be healthy and free of disease as determined by evaluation of a medical history
- •Body mass index (BMI) between 18.5 - 30 kg/m^2
排除标准
- •Those individuals less than 18 and greater than 45 years of age will be excluded.
- •Participants younger than 18 are excluded due to necessity of parental consent.
- •Participants greater than 45 years old lie outside of the target demographic for the current study.
- •As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with any cardiac, respiratory, endocrine, psychiatric, musculoskeletal, renal, hepatic, neuromuscular or metabolic disease or disorder.
- •Additional exclusion criteria include: participants with a fasting capillary blood glucose level > 100 mg/dL.
- •Current smokers (including vaping) or have quit within the past six months.
- •Any over-the-counter or prescription drugs and/or dietary supplements that are known or are purported to impact glycemia and insulinemia.
- •Currently or have been following with the past 30 days a ketogenic or very-low carbohydrate diet.
- •Participants who are determined to not be weight stable defined as measured body mass deviating by 2% or more.
结局指标
主要结局
Dihydroberberine 100
时间窗: 30 days
Changes in plasma berberine levels after supplementing 100 mg of dihyrdoberberine
Insulin
时间窗: 30 days
Changes in insulin levels after supplementing either berberine or dihyrdoberberine
Dihydroberberine 200
时间窗: 30 days
Changes in plasma berberine levels after supplementing 200 mg of dihyrdoberberine
Berberine
时间窗: 30 days
Changes in plasma berberine levels after supplementing 500 mg of berberine
Glucose
时间窗: 30 days
Changes in plasma glucose levels after supplementing either berberine or dihyrdoberberine
次要结局
未报告次要终点