Investigating the Evolutionary Impact of Metabolic Flexibility on Physical Activity-Dependent BDNF and Cognition: Insights From the Val66Met Polymorphism
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Serum BDNF
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy young adults
- •18 years old to 35 years old
- •give informed consent
Exclusion Criteria
- •Diabetics
- •history of low blood sugar
- •limited physical abilities unable to participate in an aerobic treadmill test
Arms & Interventions
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.
Intervention: 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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Serum BDNF
Time Frame: 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.
Secondary Outcomes
- Cognition(baseline, pre-intervention/procedure/surgery, and immediately after the intervention/procedure/surgery)
Investigators
David Raichlen
Professor
University of Southern California