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

University of Southern California

Status and phase: Not yet enrolling; Phase 1

Conditions: Cognition; BDNF

Treatments: Drug: d-beta-hydroxybutrate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07218497

APP-24-05903

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Ketosis Trial

Experimental group

Description:

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.

Treatment:

Drug: d-beta-hydroxybutrate

Placebo Trial

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo