Cognition ImprovementMITOCOGNCT07793604
Increasing Mitochondrial Respiration as a Novel Mechanism for Cognitive Augmentation
A study testing Active transcranial photobiomodulation and Active MCT dietary supplementation in people with Cognition Improvement and Emotion Regulation, run by Francisco Gonzalez-Lima, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition Improvement, Emotion Regulation
- What is being tested?
- Active transcranial photobiomodulation and Active MCT dietary supplementation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-85 years old
- No uncorrected visual, auditory, or motor impairments that would interfere with performing cognitive tasks
Who cannot join
- Transcranial photobiomodulation in the last six weeks
- Diabetes
- Pregnancy or plans to become pregnant
- Breastfeeding or plans to breastfeed
- Major depressive disorder
- Psychotic disorders
Show all 11Show fewer
- 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
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
The University of Texas at Austin
Austin, Texas, 78712
About this study
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.
Read the 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.
- Conditions
- Cognition Improvement, Emotion Regulation
- Being tested
- Active transcranial photobiomodulation, Active MCT dietary supplementation, Sham photobiomodulation, Sham dietary supplementation
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial photobiomodulationDevice
Infrared light delivered to the forehead, administered with a headset using light-emitting diodes (LEDs)
Active MCT dietary supplementationDietary supplement
Commercially-available food-grade refined coconut oil for ketogenic dietary supplementation
Sham photobiomodulationDevice
Identical procedure as active group, but with 5% of light emitted by the device.
Sham dietary supplementationDietary supplement
Identical appearance and administration as active dietary supplementation, but with commercially-available food-grade sunflower oil (comparable caloric value without ketone production).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: active tPBM, active MCT dietary supplementation | Active comparator | 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. Receives: Device: Active transcranial photobiomodulation; Dietary Supplement: Active MCT dietary supplementation |
| Arm 2: sham tPBM, sham dietary supplementation | Sham comparator | 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). Receives: Device: Sham photobiomodulation; Dietary Supplement: Sham dietary supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: 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 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.
Measured: The DMS will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Weekly check-in
Open response, verification of compliance of treatment
Measured: Once per week during treatment
Follow-up
Open response of any long-term effects of treatment
Measured: One month after Visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognition ImprovementStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Gonzalez-Lima, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Gonzalez-Lima, PhD, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793604
- Sponsor's protocol ID
- STUDY00009139
- Acronym
- MITOCOG
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 24316434
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Mitochondrial Respiration as a Novel Mechanism for Cognitive Augmentation
- ClinicalTrials.gov ID
- NCT07793604
- Acronym / sponsor ID
- MITOCOG / STUDY00009139
- Conditions
- Cognition Improvement, Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Francisco Gonzalez-Lima, PhDUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: active tPBM, active MCT dietary supplementation | Active comparator | Device: Active transcranial photobiomodulation, Dietary Supplement: Active MCT dietary supplementationParticipants 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 comparator | Device: Sham photobiomodulation, Dietary Supplement: Sham dietary supplementationParticipants 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18-85 years old
- No uncorrected visual, auditory, or motor impairments that would interfere with performing cognitive tasks
Key exclusion criteria (11 listed)
- Transcranial photobiomodulation in the last six weeks
- Diabetes
- Pregnancy or plans to become pregnant
- Breastfeeding or plans to breastfeed
- Major depressive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active transcranial photobiomodulationInfrared light delivered to the forehead, administered with a headset using light-emitting diodes (LEDs) | Device | Arm 1: active tPBM, active MCT dietary supplementation |
| Active MCT dietary supplementationCommercially-available food-grade refined coconut oil for ketogenic dietary supplementation | Dietary supplement | Arm 1: active tPBM, active MCT dietary supplementation |
| Sham photobiomodulationIdentical procedure as active group, but with 5% of light emitted by the device. | Device | Arm 2: sham tPBM, sham dietary supplementation |
| Sham dietary supplementationIdentical appearance and administration as active dietary supplementation, but with commercially-available food-grade sunflower oil (comparable caloric value without ketone production). | Dietary supplement | Arm 2: sham tPBM, sham dietary supplementation |
Primary outcome
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.
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.
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.
4 secondary outcomes
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)
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)
Weekly check-in
Time frame: Once per week during treatment
Follow-up
Time frame: One month after Visit 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 24316434Gonzalez-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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial photobiomodulation and Active MCT dietary supplementation in people with Cognition Improvement and Emotion Regulation, run by Francisco Gonzalez-Lima, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Gonzalez-Lima ((512) 703-1804, utcognitivestudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07793604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.