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

Northumbria University

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Supradyn® Energy 3RDA

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03003442

18769

Details and patient eligibility

About

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.

Full 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.

Enrollment

91 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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