Effects of Supradyn® Energy 3RDA on Fatigue/Stress, Substrate Metabolism During Exercise and Dema… (NCT03003442) | Clinical Trial Compass
CompletedNot Applicable
Effects of Supradyn® Energy 3RDA on Fatigue/Stress, Substrate Metabolism During Exercise and Demanding Cognitive Tasks
United Kingdom91 participantsStarted 2016-11-01
Plain-language summary
Investigation of the acute and chronic effects of Supradyn® Energy 3RDA on subjective ratings of 'fatigue/stress', substrate metabolism and blood biomarkers of recovery, as a consequence of exercise and metabolically demanding cognitive tasks.
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects are physically active (i.e. exercise at least 2 times per week)
* Subjects are able to run non-stop on a treadmill at a moderate pace for 30mins
* Subjects agree to abstain throughout the trial from all dietary vitamin and mineral supplements
* Subjects are, in the opinion of the investigator, willing to participate in all scheduled visits and to adhere to all study procedures
* Subjects accept to refrain from alcohol intake 24 hours and to fast for a minimum of 10 hours before the study visits
* Subjects do not have a current diagnosis of a significant medical condition which may interfere with the subject's ability to perform assessments and successfully completes training
* Subjects provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial and understood and accepts these
* Have a bank account (required for payment)
Exclusion Criteria:
* Smokers (smoking within the last 3 months)
* Blood pressure \>140/90mmHg
* Excessive use of caffeine (\> 500 mg caffeine per day) from all dietary sources
* Current intake of pharmaceuticals (excluding contraception)
* Have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units)
* A history of neurological or psychiatric diseases excluding anxiety or depression
* Current diagn…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute treatment effects on energy expenditure/metabolism during physical stress
Timeframe: Measures taken following acute treatment during exercise (45 minutes post acute treatment)
2
Acute treatment effects on energy expenditure/metabolism during mental stress
Timeframe: Measures taken following acute treatment during cognitive task performance (135 minutes post acute treatment)
3
Chronic treatment effects on energy expenditure/metabolism during physical stress
Timeframe: Measures taken following 28 days' chronic treatment, during exercise performance
4
Chronic treatment effects on energy expenditure/metabolism during mental stress
Timeframe: Measures taken following 28 days' chronic treatment, during cognitive task performance
5
Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during physical stress
Timeframe: Following acute treatment, measures taken before, after and every 10 minutes during 30 minute exercise period
6
Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during mental stress.
Timeframe: Following acute treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period
7
Chronic (28 days) treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales, during physical stress
Timeframe: Following 28 days' treatment, measures taken before, after and every 10 minutes during 30 minute exercise period
8
Chronic (28 days) treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales, during mental stress
Timeframe: Following 28 days treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period
9
Acute treatment effects on recovery biomarkers
Timeframe: Following acute treatment, taken at baseline and following exercise (75 minutes post-dose) and cognitive task performance (165 minutes post-dose). Then at 24h and 48hours post-exercise.
10
Chronic (28 days) treatment effects on recovery biomarkers
Timeframe: Following 28 days treatment, taken at baseline, following exercise and cognitive task performance. Then at 24h and 48hours post-exercise.