Increasing Mitochondrial Respiration as a Novel Mechanism for Cognitive Augmentation (MITOCOG)

August 26, 2026 updated by: Francisco Gonzalez-Lima, PhD
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Gonzalez-Lima Laboratory at the University of Texas at Austin is recruiting participants for a research study. The study examines whether a combined treatment can improve cognitive function. The treatment includes transcranial photobiomodulation (tPBM), a form of light therapy applied to the forehead, along with a dietary supplement. The treatment targets an enzyme called cytochrome-c-oxidase, which plays a key role in how the mitochondria inside brain cells use oxygen to produce energy. As people age, this process often becomes less efficient, contributing to cognitive decline seen in normal aging and in neurodegenerative diseases. The hypothesis is that improving mitochondrial function and cytochrome-c-oxidase activity will boost neuronal energy production and reduce oxidative stress, ultimately enhancing cognitive performance. Previous studies from the Gonzalez-Lima Lab found that applying tPBM to the prefrontal cortex improves brain metabolic activity and enhances cognitive functions such as attention, memory, and executive function. The dietary supplement provides an alternative energy source derived from ketones, which mitochondria can use for oxygen metabolism. This may help bypass the impaired glucose metabolism often seen in aging brains, potentially leading to further cognitive improvements. This study will investigate the cognitive effects of this combined treatment in adults ages 18 to 85. During the first visit to the lab, participants will complete informed consent, health questionnaires, and cognitive assessments, and wear sensors on the head which monitor brain activity. They will also be trained to use a headset device which uses light-emitting diodes (LEDs) to deliver light to the forehead. They will be given daily supplements and instructed on how to maintain a daily log for at-home treatments. Then, for the next two months, participants will complete the daily protocol at home. Weekly check-ins will monitor progress throughout this period. After two months, participants will return to repeat the assessments from the first visit and return their study materials. Participants will receive $200 upon completing the study, and parking expenses will be reimbursed for each visit. Briefly, one aim will be to map the relationship between baseline prefrontal functional connectivity and dimensional performance in cognitive control and affective processing. Another aim will be to evaluate mechanistic efficacy of chronic tPBM in engaging prefrontal circuits and restoring task-based behavioral performance. A final aim is to model the longitudinal relationship between prefrontal circuit health and real-world sleep, circadian stability, and neuroendocrine regulation. By focusing on target-driven biobehavioral mechanisms, this study aims to identify novel therapeutic targets and establish scalable biomarker pipelines.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • The University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: 18-85 years old
  • No uncorrected visual, auditory, or motor impairments that would interfere with performing cognitive tasks

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Active transcranial photobiomodulation
Infrared light delivered to the forehead, administered with a headset using light-emitting diodes (LEDs)
Dietary supplement: Active MCT dietary supplementation
Commercially-available food-grade refined coconut oil for ketogenic dietary supplementation
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).
Device: Sham photobiomodulation
Identical procedure as active group, but with 5% of light emitted by the device.
Dietary supplement: Sham dietary supplementation
Identical appearance and administration as active dietary supplementation, but with commercially-available food-grade sunflower oil (comparable caloric value without ketone production).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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
Time Frame: The TMT will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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)
Time Frame: The fNIRS procedure will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive assessment: 2-Back Task
Time Frame: The 2-back task will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
The 2-back task is a standard computer-based test that assesses attention and short-term memory, in which participants remember a series of letters presented onscreen. Accuracy (number of errors) and speed (reaction time in seconds) are recorded. Faster time and lower errors=better performance. Duration: 5 minutes.
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)
Time Frame: The DMS will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
The DMS is a standard computer-based test that assesses visuospatial memory and attention, in which participants remember a grid pattern through a delay and then identify the correct match. Number of correct responses and reaction time in seconds are measured. Faster time and lower errors=better performance. Duration=5 minutes.
The DMS will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Weekly check-in
Time Frame: Once per week during treatment
Open response, verification of compliance of treatment
Once per week during treatment
Follow-up
Time Frame: One month after Visit 2
Open response of any long-term effects of treatment
One month after Visit 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Francisco Gonzalez-Lima, PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00009139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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