Increasing Mitochondrial Respiration as a Novel Mechanism for Cognitive Augmentation

Part of paid clinical trials in Austin, Texas.

Sponsor
Francisco Gonzalez-Lima, PhD
Study ID
NCT07793604
Status
Not Yet Recruiting

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Conditions

  • Cognition Improvement
  • Emotion Regulation

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Active transcranial photobiomodulation — DEVICE
    Infrared light delivered to the forehead, administered with a headset using light-emitting diodes (LEDs)
  • Active MCT dietary supplementation — DIETARY_SUPPLEMENT
    Commercially-available food-grade refined coconut oil for ketogenic dietary supplementation
  • Sham photobiomodulation — DEVICE
    Identical procedure as active group, but with 5% of light emitted by the device.
  • Sham dietary supplementation — DIETARY_SUPPLEMENT
    Identical appearance and administration as active dietary supplementation, but with commercially-available food-grade sunflower oil (comparable caloric value without ketone production).

Study Details

The purpose of this study is to investigate the effects of increasing brain energy on cognition. The hypothesis is that by using a special kind of light, in combination with a nutritional supplement, it may be possible to increase energy production in the brain, which may lead to improvements in cognition.

Key Dates

First listed
Aug 28, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER

Arms

  • Active Comparator: Arm 1: active tPBM, active MCT dietary supplementation
    Participants in this arm will receive active transcranial photobiomodulation to the forehead, targeting prefrontal cortex, and active dietary supplementation with refined coconut oil to provide ketones.
  • Sham Comparator: Arm 2: sham tPBM, sham dietary supplementation
    Participants in this arm will undergo the same procedures as the active group, but with sham photobiomodulation (5% of experimental light emitted by the device) and sham dietary supplementation with sunflower oil (comparable caloric value without ketone production).

Primary Outcome Measure

Cognitive assessment: Montreal Cognitive Assessment (MoCA) [ Time Frame: The MoCA will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas at AustinAustinTexas78712-

Find similar trials in Austin, TX

By research site
The University of Texas at Austin· Austin, TX

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