Investigating the Evolutionary Impact of Metabolic Flexibility on Physical Activity-Dependent BDNF and Cognition: Insights From the Val66Met Polymorphism
NCT ID: NCT07218497
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2025-11-01
2027-05-01
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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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.
d-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.
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.
Placebo
Participants will consume a placebo consisting of a pure electrolyte drink.
Interventions
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d-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.
Placebo
Participants will consume a placebo consisting of a pure electrolyte drink.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years old to 35 years old
* give informed consent
Exclusion Criteria
* history of low blood sugar
* limited physical abilities unable to participate in an aerobic treadmill test
18 Years
35 Years
ALL
Yes
Sponsors
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University of Southern California
OTHER
Responsible Party
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David Raichlen
Professor
Locations
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University of Southern California
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APP-24-05903
Identifier Type: -
Identifier Source: org_study_id
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