Investigating the Evolutionary Impact of Metabolic Flexibility on Physical Activity-Dependent BDNF and Cognition: Insights From the Val66Met Polymorphism
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Serum BDNF
研究概览
简要总结
The goal of this clinical trial is to learn if a state of ketosis and physical activity will increase serum BDNF concentrations and improve cognition, specifically in individuals who possess the Met allele from the BDNF Val66Met SNP. The main questions it aims to answer are:
- Does the combination of ketosis and physical activity increase serum BDNF concentrations and cognition?
- Do Met Carriers of the BDNF Val66Met SNP demonstrate a significantly larger change in serum BDNF after physical activity and a state of ketosis compared to Val/Val Homozygotes?
- Do Met Carriers of the BDNF Val66Met SNP demonstrate a significantly larger increase in cognition after physical activity and a state of ketosis compared to Val/Val Homozygotes?
Researchers will compare a ketosis supplement to a placebo (a look-alike substance that contains no drug) to see if the ketosis supplement and physical activity increases serum BDNF and improves cognition.
Participants will:
- Participate in a drug trial where they will be given the ketosis supplement, and a placebo trial where they will ingest a placebo.
- Participants will donate a whole blood sample and take a cognitive test before and after the ketosis and placebo trial.
- Participants will take a 30-minute treadmill test during both the ketosis and placebo trial, after ingesting either the drug or placebo for each respective trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy young adults
- •18 years old to 35 years old
- •give informed consent
排除标准
- •Diabetics
- •history of low blood sugar
- •limited physical abilities unable to participate in an aerobic treadmill test
研究组 & 干预措施
Ketosis Trial
Participants will be given a sugar-free electrolyte mixture with d-beta-hydroxybutrate to drink in a 1:1 ratio calculated to 0.1816g/lb based on body weight before the treadmill test.
干预措施: d-beta-hydroxybutrate (Drug)
Placebo Trial
Participants consume a placebo consisting of a pure sugar-free electrolyte drink before treadmill test. The grams of placebo will be calculated 0.1816g/lb based on body weight.
干预措施: Placebo (Drug)
结局指标
主要结局
Serum BDNF
时间窗: baseline, pre-intervention/procedure/surgery, and immediately after the intervention/procedure/surgery
Whole blood will be taken from participants before and after the treadmill test for both placebo and ketosis trial days. Serum will be extracted and an ELIZA will be run to assess serum BDNF concentrations.
次要结局
- Cognition(baseline, pre-intervention/procedure/surgery, and immediately after the intervention/procedure/surgery)
研究者
David Raichlen
Professor
University of Southern California