Increasing Mitochondrial Respiration as a Novel Mechanism for Cognitive Augmentation (MITOCOG)
26 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
180
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Francisco Gonzalez-Lima
- Numéro de téléphone: (512) 703-1804
- E-mail: utcognitivestudy@gmail.com
Lieux d'étude
-
-
Texas
-
Austin, Texas, États-Unis, 78712
- The University of Texas at Austin
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
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
|
|
Comparateur factice: 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).
|
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).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognitive assessment: Montreal Cognitive Assessment (MoCA)
Délai: 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
Délai: 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)
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognitive assessment: 2-Back Task
Délai: 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)
Délai: 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
Délai: Once per week during treatment
|
Open response, verification of compliance of treatment
|
Once per week during treatment
|
|
Follow-up
Délai: One month after Visit 2
|
Open response of any long-term effects of treatment
|
One month after Visit 2
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
1 décembre 2029
Achèvement de l'étude (Estimé)
1 mai 2030
Dates d'inscription aux études
Première soumission
19 août 2026
Première soumission répondant aux critères de contrôle qualité
26 août 2026
Première publication (Réel)
28 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00009139
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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).
Délai de partage IPD
Beginning 9 months and ending 36 months following article publication.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .