Increasing Mitochondrial Respiration as a Novel Mechanism for Cognitive Augmentation (MITOCOG)
2026年8月26日 更新者：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.
調査の概要
状態
状態
まだ募集していません
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
介入
入学 (推定)
入学
180
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Francisco Gonzalez-Lima
- 電話番号：(512) 703-1804
- メール：utcognitivestudy@gmail.com
研究場所
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Texas
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Austin、Texas、アメリカ、78712
- The University of Texas at Austin
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：4倍
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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
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偽コンパレータ：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).
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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).
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cognitive assessment: Montreal Cognitive Assessment (MoCA)
時間枠：The MoCA will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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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.
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The MoCA will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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Cognitive assessment: Trail-Making Test
時間枠：The TMT will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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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.
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The TMT will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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Brain metabolism assessment: Functional Near-Infrared Spectroscopy (fNIRS)
時間枠：The fNIRS procedure will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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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.
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The fNIRS procedure will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cognitive assessment: 2-Back Task
時間枠：The 2-back task will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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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.
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The 2-back task will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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Cognitive assessment: Delayed Match-to-Sample Task (DMS)
時間枠：The DMS will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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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.
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The DMS will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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Weekly check-in
時間枠：Once per week during treatment
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Open response, verification of compliance of treatment
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Once per week during treatment
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Follow-up
時間枠：One month after Visit 2
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Open response of any long-term effects of treatment
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One month after Visit 2
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
研究開始
2026年10月1日
一次修了 (推定)
一次修了
2029年12月1日
研究の完了 (推定)
研究の完了
2030年5月1日
試験登録日
最初に提出
最初に提出
2026年8月19日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年8月26日
最初の投稿 (実際)
最初の投稿
2026年8月28日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年8月28日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年8月26日
最終確認日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- STUDY00009139
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Beginning 9 months and ending 36 months following article publication.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。