- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03003442
Effects of Supradyn® Energy 3RDA on Fatigue/Stress, Substrate Metabolism During Exercise and Demanding Cognitive Tasks
March 12, 2018 updated by: Northumbria University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne & Wear
-
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 8ST
- Northumbria University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Supradyn® Energy 3RDA
Supradyn® Energy 3RDA, 1 multivitamin/mineral tablet administered by mouth daily for 28 days
|
Multivitamin/mineral containing co-Q10
|
PLACEBO_COMPARATOR: Placebo
Placebo, 1 tablet administered by mouth daily for 28 days
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Measures taken following acute treatment during exercise (45 minutes post acute treatment)
|
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
|
Measures taken following acute treatment during cognitive task performance (135 minutes post acute treatment)
|
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
|
Measures taken following 28 days' chronic treatment, during exercise performance
|
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
|
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
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)
|
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.
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)
|
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
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)
|
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
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)
|
Following 28 days treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period
|
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
|
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
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
|
Following 28 days treatment, taken at baseline, following exercise and cognitive task performance. Then at 24h and 48hours post-exercise.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute treatment effects on vitamin/mineral/homocysteine levels
Time Frame: Measured at baseline, then following acute treatment, after exercise (75 minutes post-dose)
|
Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine
|
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
|
Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine
|
Following chronic (28 days) treatment, measured after exercise
|
Acute treatment effects on cognitive performance
Time Frame: Following acute treatment, measured 135 minutes post dose
|
Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times
|
Following acute treatment, measured 135 minutes post dose
|
Chronic (28 days) treatment effects on cognitive performance
Time Frame: Following chronic (28 days) treatment
|
Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times
|
Following chronic (28 days) treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2016
Primary Completion (ACTUAL)
October 16, 2017
Study Completion (ACTUAL)
October 18, 2017
Study Registration Dates
First Submitted
November 22, 2016
First Submitted That Met QC Criteria
December 21, 2016
First Posted (ESTIMATE)
December 28, 2016
Study Record Updates
Last Update Posted (ACTUAL)
March 13, 2018
Last Update Submitted That Met QC Criteria
March 12, 2018
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18769
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States