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

NCT ID: NCT03003442

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2017-10-18

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Supradyn® Energy 3RDA

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

Group Type: EXPERIMENTAL

Supradyn® Energy 3RDA

Intervention Type: DIETARY_SUPPLEMENT

Multivitamin/mineral containing co-Q10

Placebo

Placebo, 1 tablet administered by mouth daily for 28 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

Supradyn® Energy 3RDA

Multivitamin/mineral containing co-Q10

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Crystal Haskell-Ramsay, Dr

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

Northumbria University

Newcastle upon Tyne, Tyne & Wear, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32123534 (View on PubMed)

Other Identifiers

18769

Identifier Type: -

Identifier Source: org_study_id