Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374641
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-03-12
Brief Title:
The Effects of a Novel Mitochondrial Substrate Supplement on Exercise Performance and Cognitive Function
Sponsor:
University of Exeter
Organization:
University of Exeter
Study Overview
Official Title:
The Effects of a Novel Mitochondrial Substrate Supplement on Exercise Performance and Cognitive Function
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MCh1
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 doesnt 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
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
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 andor 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 mLd-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
The supplement is composed of three bioactive components choline nicotinamide and succinate All three components are available on the market as supplements andor 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 mLd-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None