protocolSection identificationModule nctId: NCT06374641, orgStudyIdInfo id: 5514255, briefTitle: The Effects of a Novel Mitochondrial Substrate Supplement on Exercise Performance and Cognitive Function, acronym: MCh1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Exeter, class: OTHER, collaborators name: Mitocholine Ltd, collaborators name: Innovate UK, descriptionModule briefSummary: The goal of this clinical trial is to compare the effects of taking a new supplement for 16 days on cognitive function and exercise performance, compared to a placebo (a supplement that looks and tastes the same, but doesn't have the same ingredients) in 40 healthy individuals - 20 young individuals (aged 18-30) and 20 older individuals (aged 50-65).The main questions it aims to answer are:* If taking the supplement for 16 days improves exercise performance, or the speed with which the body responds to the commencement of exercise.* If taking the supplement improves cognitive function.Participants will visit the lab on 5 separate occasions to:* complete some cognitive tests* complete exercise performance tests* provide blood samplesAll exercise tests will be on an exercise bike.After 28 (or 46 for pre-menopausal females) days to make sure the supplement has left the body fully, participants will consume the opposite supplement and repeat the tests., conditionsModule conditions: Exercise Performance, conditions: Cognitive Function, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Trials will be randomised and counterbalanced to remove any trial-order effect., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Partners Innovate UK and Mitocholine Ltd will also be masked. Masking will be performed by an individual outside of the research group., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Mitochondrial Substrate Supplement, interventions name: Placebo Supplement, outcomesModule primaryOutcomes measure: Exercise Capacity, primaryOutcomes measure: VO2 kinetic response to exercise, primaryOutcomes measure: Cognitive Function (Stroop test), primaryOutcomes measure: Cognitive Function (decision reaction test), primaryOutcomes measure: Grip Strength, secondaryOutcomes measure: Capillary Blood Lactate, secondaryOutcomes measure: Questionnaire 1, secondaryOutcomes measure: Questionnaire 2, secondaryOutcomes measure: Venous Blood [Betaine], secondaryOutcomes measure: Venous Blood [Choline], secondaryOutcomes measure: Venous blood [S-Adenosyl methionine], secondaryOutcomes measure: Venous blood [glucose]., secondaryOutcomes measure: Venous blood [insulin]., secondaryOutcomes measure: Venous blood [trimethylamine N-oxide]., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Richards Building St. Lukes Campus University of Exeter, status: RECRUITING, city: Exeter, state: Devon, zip: EX2 4TH, country: United Kingdom, contacts name: Jimmy T Wangdi, PhD, role: CONTACT, phone: 01392 661000, email: j.Wangdi4@exeter.ac.uk, contacts name: Matthew I Black, PhD, role: CONTACT, email: M.I.Black@exeter.ac.uk, geoPoint lat: 50.7236, lon: -3.52751, hasResults: False