NCT03003442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2017

Completed
Last Updated

March 13, 2018

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

November 22, 2016

Last Update Submit

March 12, 2018

Conditions

Healthy

Keywords

Multivitamin/mineralExerciseFatigueStressArousalEnergy expenditureRecovery biomarkersCognition

Outcome Measures

Primary Outcomes (10)

  • Acute treatment effects on energy expenditure/metabolism during physical stress

    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

    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

    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

    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

    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.

    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

    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

    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

    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

    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 Outcomes (4)

  • Acute treatment effects on vitamin/mineral/homocysteine levels

    Measured at baseline, then following acute treatment, after exercise (75 minutes post-dose)

  • Chronic (28 days) treatment effects on vitamin/mineral/homocysteine levels

    Following chronic (28 days) treatment, measured after exercise

  • Acute treatment effects on cognitive performance

    Following acute treatment, measured 135 minutes post dose

  • Chronic (28 days) treatment effects on cognitive performance

    Following chronic (28 days) treatment

Study Arms (2)

Supradyn® Energy 3RDA

EXPERIMENTAL

Supradyn® Energy 3RDA, 1 multivitamin/mineral tablet administered by mouth daily for 28 days

Dietary Supplement: Supradyn® Energy 3RDA

Placebo

PLACEBO COMPARATOR

Placebo, 1 tablet administered by mouth daily for 28 days

Dietary Supplement: Placebo

Interventions

Supradyn® Energy 3RDADIETARY_SUPPLEMENT

Multivitamin/mineral containing co-Q10

Supradyn® Energy 3RDA
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

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

Location

Related Publications (1)

  • 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.

    PMID: 32123534DERIVED

MeSH Terms

Conditions

CalcinosisMotor ActivityFatigue

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Crystal Haskell-Ramsay, Dr

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2016

First Posted

December 28, 2016

Study Start

November 1, 2016

Primary Completion

October 16, 2017

Study Completion

October 18, 2017

Last Updated

March 13, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)