CognitionPhase 1NCT07218497
Investigating the Evolutionary Impact of Metabolic Flexibility on Physical Activity-Dependent BDNF and Cognition: Insights From the Val66Met Polymorphism
A Phase 1 study testing d-beta-hydroxybutrate in people with Cognition and BDNF, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- d-beta-hydroxybutrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 1 May 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults
- 18 years old to 35 years old
- give informed consent
Who cannot join
- Diabetics
- history of low blood sugar
- limited physical abilities unable to participate in an aerobic treadmill test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Southern California
Los Angeles, California, 90089
Anamika Nanda, 4254639902, anamikananda@outlook.com
Anamika Nanda
About this study
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?
Read more
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.
- Being tested
- d-beta-hydroxybutrate, Placebo
- Keywords
- Cognition, BDNF, Val66Met SNP, Physical Activity, Ketosis
- Medical subject headings
- Motor Activity, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-beta-hydroxybutrateDrug
Also called Ketosis Supplement
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.
PlaceboDrug
Participants will consume a placebo consisting of a pure electrolyte drink.
| Study group | Role | What they receive |
|---|---|---|
| Ketosis Trial | Experimental | 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. Receives: Drug: d-beta-hydroxybutrate |
| Placebo Trial | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum BDNF
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.
Measured: baseline, pre-intervention/procedure/surgery, and immediately after the intervention/procedure/surgery
Secondary outcomes (1)
Cognition
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.
Measured: baseline, pre-intervention/procedure/surgery, and immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Raichlen, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218497
- Sponsor's protocol ID
- APP-24-05903
- Status last verified
- Oct 2025
- First submitted
- 12 Sep 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: At this time we do not intend to share IPD to protect their anonymity