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

NCT06374641 | Recruiting

• 1 other identifier: 5514255
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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 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.

Conditions

Exercise Performance; Cognitive Function

Keywords

choline; nicotinamide; succinate; supplement; exercise; cognitive function

Outcome Measures

Primary Outcomes (5)

• 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.

  Day 15 and 16

• 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.

  Day 16

• Cognitive Function (Stroop test)

  Cognitive function tested via Stroop test administered by computerised system.

  Day 15

• Cognitive Function (decision reaction test)

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

  Day 15

• Grip Strength

  Grip strength measured by hand strength dynamometer.

  Day 15

Secondary Outcomes (9)

• Capillary Blood Lactate

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

• Questionnaire 1

  Day 16

• Questionnaire 2

  Day 15

• Venous Blood [Betaine]

  Day 15

• Venous Blood [Choline]

  Day 15

Study Arms (2)

Mitochondrial Substrate Supplement then Placebo

EXPERIMENTAL

Administered 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).

Dietary Supplement: Mitochondrial Substrate Supplement; Dietary Supplement: Placebo Supplement

Placebo then Mitochondrial Substrate Supplement

PLACEBO COMPARATOR

Administered 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).

Dietary Supplement: Mitochondrial Substrate Supplement; Dietary Supplement: Placebo Supplement

Interventions

Mitochondrial Substrate Supplement DIETARY_SUPPLEMENT

Mitochondrial Substrate supplement, 2xdaily 65 mL drink

Also known as: Mitocholine, MiBrain

Mitochondrial Substrate Supplement then Placebo; Placebo then Mitochondrial Substrate Supplement

Placebo Supplement DIETARY_SUPPLEMENT

Placebo supplement, 2xdaily 65 mL drink

Mitochondrial Substrate Supplement then Placebo; Placebo then Mitochondrial Substrate Supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• Mitocholine Ltd: collaborator
• Innovate UK: collaborator

Study Sites (1)

Richards Building St. Lukes Campus University of Exeter

Exeter, Devon, EX2 4TH, United Kingdom

RECRUITING

Related Publications (3)

• 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.

  PMID: 17473782 RESULT

• 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.

  PMID: 19661447 RESULT

• 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.

  PMID: 22033512 RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Andy M Jones, PhD, DSc

  University of Exeter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimmy T Wangdi, PhD

CONTACT

441392 661000; j.Wangdi4@exeter.ac.uk

Matthew I Black, PhD

CONTACT

M.I.Black@exeter.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Partners Innovate UK and Mitocholine Ltd will also be masked. Masking will be performed by an individual outside of the research group.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Trials will be randomised and counterbalanced to remove any trial-order effect.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 18, 2024
• Study Start: March 26, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available on completion of data collection and analysis. Data will be available without an end date.
• Access Criteria: Data will be available in supplementary material for publications resulting from this study, and following requests from fellow researchers.

Locations

GB (1)