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NCT07218497 · ClinicalTrials.gov registry record · Phase 1
Investigating the Evolutionary Impact of Metabolic Flexibility on Physical Activity-Dependent BDNF and Cognition: Insights From the Val66Met Polymorphism
A Phase 1 study, sponsored by University of Southern California.
- Not yet
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT07218497: Clinical Trial Phase 1 study, sponsored by University of Southern California.
NCT07218497 is a Phase 1 study that has not yet begun recruiting, run by University of Southern California. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07218497, a Phase 1 study, has not yet begun recruiting, sponsored by University of Southern California.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG d-beta-hydroxybutrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-11-01 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 1 |
What is known before NCT07218497 opens enrollment
NCT07218497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07218497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07218497 about?
NCT07218497 is a clinical study titled "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 ...
What is the current status of trial NCT07218497?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2025-11-01. Estimated completion is 2027-05-01.
What interventions are being tested in trial NCT07218497?
The interventions under investigation include: Placebo (DRUG), d-beta-hydroxybutrate (DRUG).
Who is sponsoring clinical trial NCT07218497?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07218497's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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