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Exercise PerformanceMCh1NCT06374641

The Effects of a Novel Mitochondrial Substrate Supplement on Exercise Performance and Cognitive Function

A study testing Mitochondrial Substrate Supplement in people with Exercise Performance and Cognitive Function, run by University of Exeter at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Exercise Performance, Cognitive Function
What is being tested?
Mitochondrial Substrate Supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
26 Mar 2024to 6 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants will be deemed eligible to participate provided they are willing and able to follow the study instructions and
  • are able to take part in intense exercise (as assessed via Physical Activity Readiness Questionnaire (PARQ))
  • are able to consume a dietary supplement
  • are not overweight/obese (assessed by BMI)
  • do not have any cardiovascular, respiratory, metabolic or musculoskeletal disorders, or any other contraindication to the performance of maximal exercise.

Who cannot join

  • Aged 31-49 and aged 66+.
  • underlying illness or injury (assessed via PARQ)
  • overweight or obese individuals (BMI of >30 kg.m-2).
  • Cardiovascular, respiratory, metabolic or musculoskeletal disorders (assessed by screening form).
  • Use of dietary supplements, tobacco smoking.
  • Pregnant

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Richards Building St. Lukes Campus University of Exeter

    Exeter, Devon, EX2 4TH

Other trials in United Kingdom

About this study

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:

Read more
  • 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 samples

All 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.

Read the detailed description

This study is a randomised, placebo-controlled, cross-over trial investigating the effects of supplementing with a novel mitochondrial substrate supplement on exercise performance and cognitive function.

The supplement is composed of three bioactive components: choline, nicotinamide and succinate. All three components are available on the market as supplements and/or as food additives, but have not previously been combined.

This study will recruit 40 individuals in two cohorts. The first cohort will consist of 20 young individuals (aged 18-30) and the second cohort will consist of 20 older individuals (aged 50-65). Individuals will be block randomised into two groups within each cohort, taking either the placebo or supplement first. Trials will be counterbalanced by Latin square to remove any trial-order effect.

This study will involve 5 lab visits per participant, including a familiarisation visit and a further 2 visits per trial arm. Familiarisation will consist of questionnaires and cognitive tests, warm-up and ramp incremental test on a cycle ergometer for all participants. The ramp incremental test will commence with a 3-minute unloaded baseline period followed by an increase in work rate until task failure. Task failure will be defined as a drop by >10 rpm below participants' self-selected cadence (which is expected to lie between 70 and 100 rpm). Following a rest period, participants in the 'young' cohort will also complete a 3-minute all-out test on a cycle ergometer.

Participants will be supplemented with 65 mL.d-1 of either a placebo or the supplement twice daily for 16 days while recording food intake and exercise activities. On days 15 and 16 of supplementation, participants will return to the lab for testing. Testing on day 15 will consist of questionnaires and cognitive tests, a venous blood sample, and a 3-minute all out test (young cohort) or ramp incremental test (older cohort) on a cycle ergometer. Venous samples will be collected prior to exercise.

Testing on day 16 will consist of a series of three 6-min step tests, from unloaded to moderate intensity, with a 15-minute rest period between each test. Moderate exercise is defined as exercise which occurs below the lactate threshold. Participants will then complete an intermittent exercise protocol consisting of alternating 60-second periods of severe intensity exercise and 30-second periods of recovery until they reach the limit of tolerance. Severe intensity is defined as exercise which occurs above the critical power, where VO2max is reached at exhaustion. All tests will be conducted on a cycle ergometer.

Following completion of the first trial arm, participants will undergo a 28 or 46 (pre-menopausal females) day washout period. The washout period for young female participants is adjusted to enable all testing to occur in the same phase of the menstrual cycle and thus remove potential associated confounding effects. Participants will then repeat the supplementation protocol and testing visits on days 15 and 16 with the opposing supplement.

Being tested
Mitochondrial Substrate Supplement, Placebo Supplement
Keywords
choline, nicotinamide, succinate, supplement, exercise, cognitive function
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitochondrial Substrate SupplementDietary supplement

    Also called Mitocholine, MiBrain

    Mitochondrial Substrate supplement, 2xdaily 65 mL drink

  • Placebo SupplementDietary supplement

    Placebo supplement, 2xdaily 65 mL drink

Study groups in NCT06374641
Study groupRoleWhat they receive
Mitochondrial Substrate Supplement then PlaceboExperimentalAdministered as a drink, participants receive mitochondrial substrate supplement to be taken in the morning in a fasted state in a dose of 65 mL/day twice daily for 16 days. After a washout period of 28 (or 46 for young females) days they then receive the placebo matching the mitochondrial substrate supplement to be taken in the same way, for 16 days. Each 65 mL dose of the supplement provides a dose of 481.66 mg choline, 273.01 mg succinic acid, and 15 mg nicotinamide. 65 mL of placebo consists of Aspartame (15.3 mg), Acesulfame-K (10.3 mg), Potassium Sorbate (9.1 mg), Sodium Benzoate (9.8 mg), Cellulose Gum (6.5 mg), Gluconic acid (1105.0 mg), Ginger Natural Flavouring (130.0 mg), Orange Natural Flavouring (130.0 mg), Bitter Sensation Natural Flavouring (65.0 mg), Natural Colour (colouring food) (26.0 mg), Water (63493.0 mg).
Receives: Dietary Supplement: Mitochondrial Substrate Supplement; Dietary Supplement: Placebo Supplement
Placebo then Mitochondrial Substrate SupplementPlacebo comparatorAdministered as a drink, participants receive placebo supplement matching the mitochondrial substrate supplement in taste and appearance, to be taken in a dose of 65 mL twice daily for 16 days. After a washout period of 28 (or 46 for young females) days they then receive the mitochondrial substrate supplement, to be taken in the same way, for 16 days. Each 65 mL dose of the placebo supplement provides 481.66 mg choline, 273.01 mg succinic acid, and 15 mg nicotinamide. 65 mL of placebo consists of Aspartame (15.3 mg), Acesulfame-K (10.3 mg), Potassium Sorbate (9.1 mg), Sodium Benzoate (9.8 mg), Cellulose Gum (6.5 mg), Gluconic acid (1105.0 mg), Ginger Natural Flavouring (130.0 mg), Orange Natural Flavouring (130.0 mg), Bitter Sensation Natural Flavouring (65.0 mg), Natural Colour (colouring food) (26.0 mg), Water (63493.0 mg).
Receives: Dietary Supplement: Mitochondrial Substrate Supplement; Dietary Supplement: Placebo Supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exercise Capacity

    Exercise performance as measured by ramp incremental test (older group) or 3 minute all out test (young group) and intermittent exercise test. The ramp incremental cycling test is well-established for the determination of maximal oxygen uptake (VO2max) and gaseous exchange threshold, which are key markers of cardiorespiratory health and predictor of endurance exercise performance. The 3 minute all out test is commonly used to determine critical power and W'. The critical power represents the highest power output an individual can sustain while remaining in an aerobic steady state, and the W' represents the anaerobic capacity.

    The intermittent test consists of intermittent exercise in which 1 min of severe intensity exercise is alternated with 30 s of lower intensity exercise until the participant reaches their limit of tolerance. Time to exhaustion allows for assessment of exercise capacity.

    Measured: Day 15 and 16

  2. VO2 kinetic response to exercise

    The VO2 response measured during step test from unloaded to moderate intensity exercise. The participant will cycle against a low resistance and then the resistance on the pedals will be increased abruptly to provide a moderate-intensity work rate which will be maintained for 6 minutes. The VO2 response will then be examined from the onset of exercise to the attainment of a steady state. The VO2 responses to the three step tests will be averaged and modelled to provide information on the rate at which the muscle mitochondria use oxygen to supply energy to meet the demands of the exercise. The steady-state VO2 value for the imposed work rate also allows for the assessment of exercise economy.

    Measured: Day 16

  3. Cognitive Function (Stroop test)

    Cognitive function tested via Stroop test administered by computerised system.

    Measured: Day 15

  4. Cognitive Function (decision reaction test)

    Cognitive function tested via decision reaction test administered by computerised system.

    Measured: Day 15

  5. Grip Strength

    Grip strength measured by hand strength dynamometer.

    Measured: Day 15

Secondary outcomes (9)
  1. Capillary Blood Lactate

    Capillary Blood Lactate used during step tests and intermittent exercise tests to examine the production of lactate and inferred levels of muscle acidosis.

    Measured: Before and after each step during the step test, and before and after every 2 exercise bouts during the intermittent exercise protocol.

  2. Questionnaire 1

    To assess participant experience during the supplementation period and study protocol with regard to factors such as fatigue, stress, sleep and perceived effort.

    Measured: Day 16

  3. Questionnaire 2

    To assess participant experience of the supplement with regard to factors such as perceived effects, tolerance and taste.

    Measured: Day 15

  4. Venous Blood [Betaine]

    Assessment of Venous Blood [Betaine].

    Measured: Day 15

  5. Venous Blood [Choline]

    Assessment of Venous Blood [Choline].

    Measured: Day 15

  6. Venous blood [S-Adenosyl methionine]

    Assessment of Venous Blood [S-Adenosyl methionine].

    Measured: Day 15

  7. Venous blood [glucose].

    Assessment of Venous Blood [glucose].

    Measured: Day 15

  8. Venous blood [insulin].

    Assessment of Venous Blood [insulin].

    Measured: Day 15

  9. Venous blood [trimethylamine N-oxide].

    Assessment of Venous Blood [triglycerides].

    Measured: Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start26 Mar 2024
  3. Primary completion6 Jun 2025
  4. Study completion6 Jun 2025

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Trials will be randomised and counterbalanced to remove any trial-order effect.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06374641
Sponsor's protocol ID
5514255
Acronym
MCh1
Status last verified
Nov 2025
First submitted
12 Mar 2024
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be made available as anonymised data sets of final published data in supplementary material of publications associated with this study.

Publications

  • Vanhatalo A, Doust JH, Burnley M. Determination of critical power using a 3-min all-out cycling test. Med Sci Sports Exerc. 2007 Mar;39(3):548-55. doi: 10.1249/mss.0b013e31802dd3e6.

    PubMed 17473782
  • Bailey SJ, Winyard P, Vanhatalo A, Blackwell JR, Dimenna FJ, Wilkerson DP, Tarr J, Benjamin N, Jones AM. Dietary nitrate supplementation reduces the O2 cost of low-intensity exercise and enhances tolerance to high-intensity exercise in humans. J Appl Physiol (1985). 2009 Oct;107(4):1144-55. doi: 10.1152/japplphysiol.00722.2009. Epub 2009 Aug 6.

    PubMed 19661447
  • Chidnok W, Dimenna FJ, Bailey SJ, Vanhatalo A, Morton RH, Wilkerson DP, Jones AM. Exercise tolerance in intermittent cycling: application of the critical power concept. Med Sci Sports Exerc. 2012 May;44(5):966-76. doi: 10.1249/MSS.0b013e31823ea28a.

    PubMed 22033512

Questions about this trial

What is this clinical trial studying?

A study testing Mitochondrial Substrate Supplement in people with Exercise Performance and Cognitive Function, run by University of Exeter at 1 site in United Kingdom.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 12 May 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 Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise Capacity (time frame: Day 15 and 16). The study lists 5 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 NCT06374641, which also lists 3 linked publications.

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 12 May 2026.

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