Healthy Clinical Trial
Official title:
Investigation of the Acute and Chronic Effects of Supradyn® Energy 3RDA on Ratings of 'Fatigue/Stress', Substrate Metabolism and Blood Biomarkers of Recovery, as a Consequence of Exercise and Metabolically Demanding Cognitive Tasks
Verified date | November 2017 |
Source | Northumbria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 91 |
Est. completion date | October 18, 2017 |
Est. primary completion date | October 16, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
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 diagnosis of depression or anxiety - A history of significant head trauma - Have sleep disturbances and/or are taking sleep aid medication - Have learning difficulties or dyslexia - Have visual impairment that cannot be corrected with glasses or contact lenses - Have frequent migraines that require medication (more than or equal to 1 per month) - Have disorders of the blood (e.g. anemia, hemophilia, thrombocytosis) - Have a heart disorder or a history of vascular illness - Have a respiratory disorder that is induced by exercise or requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study) - Have type I or type II diabetes - Have a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation - Are pregnant, trying to get pregnant or breast feeding - Have any health condition that would prevent fulfillment of the study requirements - Any condition which may interfere with the subjects ability to perform assessments - Are employed in a job that includes night shift work - Participation in another clinical trial within 30 days prior to screening - Have habitually supplemented with vitamins or minerals, within the last month (defined as more than 3 consecutive days or 4 days in total) - BMI above 30 kg/m2 - Any history of hypersensitivity to the investigational product or its active or inactive constituents or any food allergy or intolerance |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Northumbria University | Newcastle upon Tyne | Tyne & Wear |
Lead Sponsor | Collaborator |
---|---|
Northumbria University | Bayer |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute treatment effects on energy expenditure/metabolism during physical stress | ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation | Measures taken following acute treatment during exercise (45 minutes post acute treatment) | |
Primary | Acute treatment effects on energy expenditure/metabolism during mental stress | ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation | Measures taken following acute treatment during cognitive task performance (135 minutes post acute treatment) | |
Primary | Chronic treatment effects on energy expenditure/metabolism during physical stress | ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation | Measures taken following 28 days' chronic treatment, during exercise performance | |
Primary | Chronic treatment effects on energy expenditure/metabolism during mental stress | ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation | Measures taken following 28 days' chronic treatment, during cognitive task performance | |
Primary | Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during physical stress | Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line) | Following acute treatment, measures taken before, after and every 10 minutes during 30 minute exercise period | |
Primary | Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during mental stress. | Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line) | Following acute treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period | |
Primary | Chronic (28 days) treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales, during physical stress | Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line) | Following 28 days' treatment, measures taken before, after and every 10 minutes during 30 minute exercise period | |
Primary | Chronic (28 days) treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales, during mental stress | Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line) | Following 28 days treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period | |
Primary | Acute treatment effects on recovery biomarkers | Measuring levels of Interleukin-6, F2 isoprostanes, protein carbonyls, C-reactive protein, glutathione peroxidase, taken to assess recovery from exercise | 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. | |
Primary | Chronic (28 days) treatment effects on recovery biomarkers | Measuring levels of Interleukin-6, F2 isoprostanes, protein carbonyls, C-reactive protein, glutathione peroxidase, taken to assess recovery from exercise | Following 28 days treatment, taken at baseline, following exercise and cognitive task performance. Then at 24h and 48hours post-exercise. | |
Secondary | Acute treatment effects on vitamin/mineral/homocysteine levels | Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine | Measured at baseline, then following acute treatment, after exercise (75 minutes post-dose) | |
Secondary | Chronic (28 days) treatment effects on vitamin/mineral/homocysteine levels | Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine | Following chronic (28 days) treatment, measured after exercise | |
Secondary | Acute treatment effects on cognitive performance | Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times | Following acute treatment, measured 135 minutes post dose | |
Secondary | Chronic (28 days) treatment effects on cognitive performance | Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times | Following chronic (28 days) treatment |
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