HealthyNCT03003442
Effects of Supradyn® Energy 3RDA on Fatigue/Stress, Substrate Metabolism During Exercise and Demanding Cognitive Tasks
A study testing Supradyn® Energy 3RDA in people with Healthy, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Supradyn® Energy 3RDA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2016to 18 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne & Wear, NE1 8ST
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Supradyn® Energy 3RDA, Placebo
- Keywords
- Multivitamin/mineral, Exercise, Fatigue, Stress, Arousal, Energy expenditure, Recovery biomarkers, Cognition
- Medical subject headings
- Calcinosis, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supradyn® Energy 3RDADietary supplement
Multivitamin/mineral containing co-Q10
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Supradyn® Energy 3RDA | Experimental | Supradyn® Energy 3RDA, 1 multivitamin/mineral tablet administered by mouth daily for 28 days Receives: Dietary Supplement: Supradyn® Energy 3RDA |
| Placebo | Placebo comparator | Placebo, 1 tablet administered by mouth daily for 28 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute treatment effects on energy expenditure/metabolism during physical stress
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Measured: Measures taken following acute treatment during exercise (45 minutes post acute treatment)
Acute treatment effects on energy expenditure/metabolism during mental stress
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Measured: Measures taken following acute treatment during cognitive task performance (135 minutes post acute treatment)
Chronic treatment effects on energy expenditure/metabolism during physical stress
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Measured: Measures taken following 28 days' chronic treatment, during exercise performance
Chronic treatment effects on energy expenditure/metabolism during mental stress
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Measured: Measures taken following 28 days' chronic treatment, during cognitive task performance
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)
Measured: Following acute treatment, measures taken before, after and every 10 minutes during 30 minute exercise period
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)
Measured: Following acute treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period
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)
Measured: Following 28 days' treatment, measures taken before, after and every 10 minutes during 30 minute exercise period
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)
Measured: Following 28 days treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period
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
Measured: 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.
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
Measured: Following 28 days treatment, taken at baseline, following exercise and cognitive task performance. Then at 24h and 48hours post-exercise.
Secondary outcomes (4)
Acute treatment effects on vitamin/mineral/homocysteine levels
Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine
Measured: Measured at baseline, then following acute treatment, after exercise (75 minutes post-dose)
Chronic (28 days) treatment effects on vitamin/mineral/homocysteine levels
Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine
Measured: Following chronic (28 days) treatment, measured after exercise
Acute treatment effects on cognitive performance
Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times
Measured: Following acute treatment, measured 135 minutes post dose
Chronic (28 days) treatment effects on cognitive performance
Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times
Measured: Following chronic (28 days) treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start1 Nov 2016
- Primary completion16 Oct 2017
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Crystal Haskell-Ramsay, Dr, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003442
- Sponsor's protocol ID
- 18769
- Status last verified
- Nov 2017
- First submitted
- 22 Nov 2016
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32123534
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03003442
- Acronym / sponsor ID
- 18769
- Conditions
- Healthy
- Keywords
- Multivitamin/mineral, Exercise, Fatigue, Stress, Arousal, Energy expenditure, Recovery biomarkers, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supradyn® Energy 3RDA | Experimental | Dietary Supplement: Supradyn® Energy 3RDASupradyn® Energy 3RDA, 1 multivitamin/mineral tablet administered by mouth daily for 28 days |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo, 1 tablet administered by mouth daily for 28 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supradyn® Energy 3RDAMultivitamin/mineral containing co-Q10 | Dietary supplement | Supradyn® Energy 3RDA |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Acute treatment effects on energy expenditure/metabolism during physical stress
Time frame: Measures taken following acute treatment during exercise (45 minutes post acute treatment)
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Acute treatment effects on energy expenditure/metabolism during mental stress
Time frame: Measures taken following acute treatment during cognitive task performance (135 minutes post acute treatment)
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Chronic treatment effects on energy expenditure/metabolism during physical stress
Time frame: Measures taken following 28 days' chronic treatment, during exercise performance
ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
Chronic treatment effects on energy expenditure/metabolism during mental stress
Time frame: Measures taken following 28 days' chronic treatment, during cognitive task performance
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
Time frame: Following acute treatment, measures taken before, after and every 10 minutes during 30 minute exercise period
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.
Time frame: Following acute treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period
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
Time frame: Following 28 days' treatment, measures taken before, after and every 10 minutes during 30 minute exercise period
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
Time frame: Following 28 days treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period
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
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.
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
Time frame: Following 28 days treatment, taken at baseline, following exercise and cognitive task performance. Then at 24h and 48hours post-exercise.
Measuring levels of Interleukin-6, F2 isoprostanes, protein carbonyls, C-reactive protein, glutathione peroxidase, taken to assess recovery from exercise
4 secondary outcomes
Acute treatment effects on vitamin/mineral/homocysteine levels
Time frame: Measured at baseline, then following acute treatment, after exercise (75 minutes post-dose)
Chronic (28 days) treatment effects on vitamin/mineral/homocysteine levels
Time frame: Following chronic (28 days) treatment, measured after exercise
Acute treatment effects on cognitive performance
Time frame: Following acute treatment, measured 135 minutes post dose
Chronic (28 days) treatment effects on cognitive performance
Time frame: Following chronic (28 days) treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Derived from this study: PubMed 32123534Dodd 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Haskell-Ramsay, Dr principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supradyn® Energy 3RDA in people with Healthy, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute treatment effects on energy expenditure/metabolism during physical stress (time frame: Measures taken following acute treatment during exercise (45 minutes post acute treatment)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.