Effects of Supradyn® Energy 3RDA on Fatigue/Stress, Substrate Metabolism During Exercise and Demanding Cognitive Tasks
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Supradyn® Energy 3RDA
Placebo
Sponsored by
About this trial
This is an interventional other trial for Healthy focused on measuring Multivitamin/mineral, Exercise, Fatigue, Stress, Arousal, Energy expenditure, Recovery biomarkers, Cognition
Eligibility Criteria
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
Sites / Locations
- Northumbria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Supradyn® Energy 3RDA
Placebo
Arm Description
Supradyn® Energy 3RDA, 1 multivitamin/mineral tablet administered by mouth daily for 28 days
Placebo, 1 tablet administered by mouth daily for 28 days
Outcomes
Primary Outcome Measures
Acute treatment effects on energy expenditure/metabolism during physical stress
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Acute treatment effects on energy expenditure/metabolism during mental stress
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Chronic treatment effects on energy expenditure/metabolism during physical stress
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Chronic treatment effects on energy expenditure/metabolism during mental stress
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
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)
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)
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)
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)
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
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
Secondary Outcome Measures
Acute treatment effects on vitamin/mineral/homocysteine levels
Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine
Chronic (28 days) treatment effects on vitamin/mineral/homocysteine levels
Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine
Acute treatment effects on cognitive performance
Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times
Chronic (28 days) treatment effects on cognitive performance
Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times
Full Information
NCT ID
NCT03003442
First Posted
November 22, 2016
Last Updated
March 12, 2018
Sponsor
Northumbria University
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT03003442
Brief Title
Effects of Supradyn® Energy 3RDA on Fatigue/Stress, Substrate Metabolism During Exercise and Demanding Cognitive Tasks
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
October 16, 2017 (Actual)
Study Completion Date
October 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northumbria University
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Supplementation with vitamins and minerals has been shown to enhance energy production, metabolism, and mood state. It is thought that they may also aid recovery from challenging physical and psychological tasks following both acute and chronic supplementation. The present study will investigate the effects of a multivitamin/mineral supplement (Supradyn® Energy 3RDA) following a single intake and following daily intake for 4-weeks on subjective ratings of 'fatigue/stress', metabolism and blood biomarkers of cell damage following both exercise and demanding cognitive tasks, in healthy young male and female volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Multivitamin/mineral, Exercise, Fatigue, Stress, Arousal, Energy expenditure, Recovery biomarkers, Cognition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supradyn® Energy 3RDA
Arm Type
Experimental
Arm Description
Supradyn® Energy 3RDA, 1 multivitamin/mineral tablet administered by mouth daily for 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 1 tablet administered by mouth daily for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Supradyn® Energy 3RDA
Intervention Description
Multivitamin/mineral containing co-Q10
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Acute treatment effects on energy expenditure/metabolism during physical stress
Description
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Time Frame
Measures taken following acute treatment during exercise (45 minutes post acute treatment)
Title
Acute treatment effects on energy expenditure/metabolism during mental stress
Description
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Time Frame
Measures taken following acute treatment during cognitive task performance (135 minutes post acute treatment)
Title
Chronic treatment effects on energy expenditure/metabolism during physical stress
Description
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Time Frame
Measures taken following 28 days' chronic treatment, during exercise performance
Title
Chronic treatment effects on energy expenditure/metabolism during mental stress
Description
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Time Frame
Measures taken following 28 days' chronic treatment, during cognitive task performance
Title
Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during physical stress
Description
Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)
Time Frame
Following acute treatment, measures taken before, after and every 10 minutes during 30 minute exercise period
Title
Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during mental stress.
Description
Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)
Time Frame
Following acute treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period
Title
Chronic (28 days) treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales, during physical stress
Description
Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)
Time Frame
Following 28 days' treatment, measures taken before, after and every 10 minutes during 30 minute exercise period
Title
Chronic (28 days) treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales, during mental stress
Description
Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)
Time Frame
Following 28 days treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period
Title
Acute treatment effects on recovery biomarkers
Description
Measuring levels of Interleukin-6, F2 isoprostanes, protein carbonyls, C-reactive protein, glutathione peroxidase, taken to assess recovery from exercise
Time Frame
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.
Title
Chronic (28 days) treatment effects on recovery biomarkers
Description
Measuring levels of Interleukin-6, F2 isoprostanes, protein carbonyls, C-reactive protein, glutathione peroxidase, taken to assess recovery from exercise
Time Frame
Following 28 days treatment, taken at baseline, following exercise and cognitive task performance. Then at 24h and 48hours post-exercise.
Secondary Outcome Measure Information:
Title
Acute treatment effects on vitamin/mineral/homocysteine levels
Description
Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine
Time Frame
Measured at baseline, then following acute treatment, after exercise (75 minutes post-dose)
Title
Chronic (28 days) treatment effects on vitamin/mineral/homocysteine levels
Description
Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine
Time Frame
Following chronic (28 days) treatment, measured after exercise
Title
Acute treatment effects on cognitive performance
Description
Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times
Time Frame
Following acute treatment, measured 135 minutes post dose
Title
Chronic (28 days) treatment effects on cognitive performance
Description
Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times
Time Frame
Following chronic (28 days) treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crystal Haskell-Ramsay, Dr
Organizational Affiliation
Northumbria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northumbria University
City
Newcastle upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE1 8ST
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32123534
Citation
Dodd FL, Kennedy DO, Stevenson EJ, Veasey RC, Walker K, Reed S, Jackson PA, Haskell-Ramsay CF. Acute and chronic effects of multivitamin/mineral supplementation on objective and subjective energy measures. Nutr Metab (Lond). 2020 Feb 24;17:16. doi: 10.1186/s12986-020-00435-1. eCollection 2020.
Results Reference
derived
Learn more about this trial
Effects of Supradyn® Energy 3RDA on Fatigue/Stress, Substrate Metabolism During Exercise and Demanding Cognitive Tasks
We'll reach out to this number within 24 hrs