Increasing Mitochondrial Respiration as a Novel Mechanism for Cognitive Augmentation
MITOCOG
1 other identifier
interventional
180
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2026
CompletedFirst Posted
Study publicly available on registry
August 28, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
Study Completion
Last participant's last visit for all outcomes
May 1, 2030
August 28, 2026
August 1, 2026
3.2 years
August 19, 2026
August 26, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Cognitive assessment: Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a standard questionnaire which was developed to test for cognitive impairment. The MoCA assesses a variety of cognitive functions including executive function, memory, attention, and verbal fluency. Minimum=0; Maximum=30; low score=more impairment.
The MoCA will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Cognitive assessment: Trail-Making Test
The trail-making test (TMT) is a paper-and-pencil "connect-the-dots" task which is used to test visual attention and cognitive flexibility. Completion time (seconds) and number of errors are recorded. Faster time and lower errors=better performance. Maximum time alloted=300 seconds.
The TMT will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Brain metabolism assessment: Functional Near-Infrared Spectroscopy (fNIRS)
Participants wear a device on the head which assesses brain metabolism non-invasively using functional near-infrared spectroscopy. The device records changes in the concentrations of oxygenated hemoglobin in the prefrontal cortex of the brain.
The fNIRS procedure will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Secondary Outcomes (4)
Cognitive assessment: 2-Back Task
The 2-back task will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Cognitive assessment: Delayed Match-to-Sample Task (DMS)
The DMS will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Weekly check-in
Once per week during treatment
Follow-up
One month after Visit 2
Study Arms (2)
Arm 1: active tPBM, active MCT dietary supplementation
ACTIVE COMPARATORParticipants 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.
Arm 2: sham tPBM, sham dietary supplementation
SHAM COMPARATORParticipants 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).
Interventions
Infrared light delivered to the forehead, administered with a headset using light-emitting diodes (LEDs)
Commercially-available food-grade refined coconut oil for ketogenic dietary supplementation
Identical procedure as active group, but with 5% of light emitted by the device.
Identical appearance and administration as active dietary supplementation, but with commercially-available food-grade sunflower oil (comparable caloric value without ketone production).
Eligibility Criteria
You may qualify if:
- Age: 18-85 years old
- No uncorrected visual, auditory, or motor impairments that would interfere with performing cognitive tasks
You may not qualify if:
- Transcranial photobiomodulation in the last six weeks
- Diabetes
- Pregnancy or plans to become pregnant
- Breastfeeding or plans to breastfeed
- Major depressive disorder
- Psychotic disorders
- Suicidal ideation within the past 6 months
- Plans for serious medical procedures in the next 3 months
- Serious hepatic or liver-related conditions
- History of neurotrauma (e.g., brain lesions or traumatic brain injury)
- Presently on a ketogenic diet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas at Austin
Austin, Texas, 78712, United States
Related Publications (1)
Gonzalez-Lima F, Barksdale BR, Rojas JC. Mitochondrial respiration as a target for neuroprotection and cognitive enhancement. Biochem Pharmacol. 2014 Apr 15;88(4):584-93. doi: 10.1016/j.bcp.2013.11.010. Epub 2013 Dec 4.
PMID: 24316434BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 19, 2026
First Posted
August 28, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
May 1, 2030
Last Updated
August 28, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 9 months and ending 36 months following article publication.
- Access Criteria
- The raw data will be made available by the researchers upon reasonable request by any qualified doctoral researcher (PhD, MD). They will be granted access by contacting the corresponding author/principal investigator (F. Gonzalez-Lima, utcognitivestudy@gmail.com). It will be made available to qualified researchers whose proposed use of the data has been approved by an independent review committee (Institutional Review Board) identified for the purpose of individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in our University's shared network drive, but without investigator support other than deposited metadata.
What data will be shared? Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices). A data dictionary, including a description of the variables and types of data, collected for each individual, will be provided. This data will include anonymized individual participant demographic information and all outcome variables (cognitive task data, spectroscopy data).