The Effects of a Novel Mitochondrial Substrate Supplement on Exercise Performance and Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Grip Strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Partners Innovate UK and Mitocholine Ltd will also be masked. Masking will be performed by an individual outside of the research group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Mitochondrial Substrate Supplement then Placebo
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).
干预措施: Mitochondrial Substrate Supplement (Dietary Supplement)
Mitochondrial Substrate Supplement then Placebo
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).
干预措施: Placebo Supplement (Dietary Supplement)
Placebo then Mitochondrial Substrate Supplement
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).
干预措施: Mitochondrial Substrate Supplement (Dietary Supplement)
Placebo then Mitochondrial Substrate Supplement
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).
干预措施: Placebo Supplement (Dietary Supplement)
结局指标
主要结局
Grip Strength
时间窗: Day 15
Grip strength measured by hand strength dynamometer.
Exercise Capacity
时间窗: Day 15 and 16
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.
Cognitive Function (decision reaction test)
时间窗: Day 15
Cognitive function tested via decision reaction test administered by computerised system.
VO2 kinetic response to exercise
时间窗: Day 16
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.
Cognitive Function (Stroop test)
时间窗: Day 15
Cognitive function tested via Stroop test administered by computerised system.
次要结局
- Questionnaire 1(Day 16)
- Venous blood [glucose].(Day 15)
- 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.)
- Venous Blood [Betaine](Day 15)
- Venous blood [trimethylamine N-oxide].(Day 15)
- Venous Blood [Choline](Day 15)
- Questionnaire 2(Day 15)
- Venous blood [S-Adenosyl methionine](Day 15)
- Venous blood [insulin].(Day 15)