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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Supradyn® Energy 3RDA
Supradyn® Energy 3RDA, 1 multivitamin/mineral tablet administered by mouth daily for 28 days
Dietary supplement: Supradyn® Energy 3RDA
Multivitamin/mineral containing co-Q10
PLACEBO_COMPARATOR: Placebo
Placebo, 1 tablet administered by mouth daily for 28 days
Dietary supplement: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northumbria University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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