A Pilot Study to Determine the Bioavailability of Oral Beta-Aminoisobutyric Acid (BAIBA) Ingestion
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
- Plasma concentrations of BAIBA.
研究概览
简要总结
Think of this section as your research "elevator pitch." Please briefly describe the question(s) or issues you are addressing with your research (limited to 100 words). You will be able to provide information on specific outcomes, hypothesis, or related analysis in a following question.
Beta-amino isobutyric acid (BAIBA) is a myokine produced in skeletal muscle and has been shown to impact how our body metabolizes fuel. We seek to determine the bioavailability of different doses of orally ingested beta-aminoisobutyric acid (BAIBA).
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 five testing conditions outlined below. For each testing condition, study participants will arrive in the lab after observing an overnight fast. Upon arrival, participants will donate the first of seven venous blood samples. Follow-up blood samples will be collected at 30, 60, 90, 120, 240, 300 minutes. The first and last collected samples will be collected into one 8mL SST and three 4mL EDTA tubes, while the second, third, and forth collected samples will be into two 4mL EDTA tubes, and have aliquots of 600 ul of plasma isolated and frozen at -80oC. Collected plasma will be analyzed for changes in beta-aminoisobutyric acid (BAIBA) and biomarkers commonly assessed by physicians to evaluate healthy. Participants will observe a minimum of 48 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
Supplements blinded to participant and investigator by third party
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants will be between the ages of 18-50 years
- •All participants will be required to abstain from taking any amino acid (i.e., BCAAs, creatine, - beta-alanine, carnitine, etc.) for 14 days prior to beginning this study and for the entire duration -of the study
- •Body mass index between 18.5 - 29.9 kg/m2
- •Report accumulating at least 30 minutes of physical activity three days per week
- •All participants will be determined to be healthy through completion of a detailed health history questionnaires
排除标准
- •Are less than 18 or greater than 50 years of age. Participants younger than 18 are excluded due to necessity of parental consent. Participants greater than 50 years old are excluded due to the anticipated age-related changes that occur in digestive function, medication use, and other - associated confounding comorbidities.
- •Have a body mass index < 18.5 and > 29.9 kg/m
- •Any participant with a BMI > 29.9 kg/m2 must have a body fat percentage below 30% to be eligible.
- •No individuals with a BMI above 32.0 kg/m2 will be eligible, irrespective of their body composition.
- •Have a fasting capillary glucose (-30 minutes) level > 110 mg/dL on two separate occasions.
- •Currently smoke or have quit smoking within the past six months
- •Are currently following a ketogenic diet or a very low-carbohydrate diet for the past 30 days.
- •Any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity, immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease will be excluded.
- •Report accumulating less than 30 minutes of physical activity per day for at least three days per week.
- •Do not or are not willing to abstain from alcohol, nicotine and caffeine for 12 hours prior to each visit will be excluded
- •Do not or are not willing to abstain from exercise for 24 hours prior to each visit will be excluded.
结局指标
主要结局
Plasma concentrations of BAIBA.
时间窗: 4 hours
Plasma concentrations of BAIBA.
次要结局
- Adverse Events(4 hours)
- Complete Blood Count(4 hours)
- Comprehensive Metabolic Panel(4 hours)