Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07218497

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Southern California

Los Angeles, California, 90089, United States

Location contact

Anamika Nanda

CONTACT

[email protected]

4254639902

Anamika Nanda

SUB_INVESTIGATOR

David Raichlen, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ketosis Supplement

Placebo

Drug

Participants will consume a placebo consisting of a pure electrolyte drink.

Primary outcomes

  1. 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

  1. Cognition

    Time frame: baseline, pre-intervention/procedure/surgery, and immediately after the intervention/procedure/surgery

    RBANS, Repeatable Battery for the Assessment of Neuropsychological Status, will be administered to participants before and after each respective trial day, both placebo and ketosis trials.

Study contacts

Contact information is provided by the study sponsor or research team.

Anamika Nanda

CONTACT

[email protected]

4254639902 ext. 01

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2025
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.