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Completed

NCT Number: NCT03003442

Effects of Supradyn® Energy 3RDA on Fatigue/Stress, Substrate Metabolism During Exercise and 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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University

Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supradyn® Energy 3RDA

Dietary Supplement

Multivitamin/mineral containing co-Q10

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Bayer

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2016
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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