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

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07218497
Enrollment
50
Registered
2025-10-20
Start date
2025-11-01
Completion date
2027-05-01
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BDNF, Cognition

Keywords

Cognition, BDNF, Val66Met SNP, Physical Activity, Ketosis

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.

Interventions

DRUGd-beta-hydroxybutrate

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.

DRUGPlacebo

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

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Serum BDNFbaseline, pre-intervention/procedure/surgery, and immediately after the intervention/procedure/surgeryWhole 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

MeasureTime frameDescription
Cognitionbaseline, pre-intervention/procedure/surgery, and immediately after the intervention/procedure/surgeryRBANS, 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.

Countries

United States

Contacts

Primary ContactAnamika Nanda
anamikan@usc.edu4254639902

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026