Investigating the Evolutionary Impact of Metabolic Flexibility on Physical Activity-Dependent BDNF and Cognition: Insights From the Val66Met Polymorphism

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT07218497
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • BDNF
  • Cognition

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • d-beta-hydroxybutrate — DRUG
    During the ketosis trial, participants will be given d-beta-hydroxybutrate mixed with sugar-free gatorade in a 1:1 ratio. This is to ensure the participant's electrolytes are high and to mask the bitter taste of d-beta-hydroxybutrate. The dosage per participant will be calculated 0.1816g/lb based on body weight to ensure participants remain in a state of ketosis for a minimum of 2 hours.
  • Placebo — DRUG
    Participants will consume a placebo consisting of a pure electrolyte drink.

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Oct 2025
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Serum BDNF [ Time Frame: baseline, pre-intervention/procedure/surgery, and immediately after the intervention/procedure/surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90089
Anamika Nanda
[email protected]
4254639902
Anamika Nanda (SUB_INVESTIGATOR)
David Raichlen, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Southern California· Los Angeles, CA

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