CompletedNCT02381964Updated Mar 30, 2018

The Effects of Differing Cognitive Task Demands on Whole-body Energy Metabolism and Cerebral Blood-flow: Modulation by Multivitamins/Minerals and Coenzyme Q10

An interventional study of Supradyn® (1RDA+CoQ10) and Supradyn® (3RDA) in Metabolic Processes, sponsored by Northumbria University. Completed at 1 site in United Kingdom. Open to female participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-30.

Sponsored by Northumbria University · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 106
Allocation: Randomized
Ages: 25 Years to 50 Years
Sex: Female

Study summary

When completing difficult tasks, the brain requires faster delivery of energy sources (oxygen and glucose) via the blood. There is evidence to suggest that some nutritional supplements may increase blood circulation in the brain which can result in improved task performance. The purpose of the study is to evaluate the effects of a multivitamin/mineral preparation (containing a range of vitamins and minerals as contained in commonly consumed multivitamin/minerals available off the shelf) in healthy females on cerebral (brain) blood flow and energy expenditure during cognitive task performance.

Read the detailed description

Vitamins, minerals and CoQ10, exert a number of physiological effects directly relevant to energy supply and metabolism. Therefore it is hypothesized that the nutritional interventions in this trial will facilitate brain metabolic substrate distribution and utilisation during demanding brain activities with a potential benefit on task performance. This pilot, double-blind, placebo controlled, 3-arm parallel groups trial will utilise two concomitant non-invasive techniques:

Near Infrared Spectroscopy (NIRS) and
Indirect Calorimetry (ICa). The NIRS will be utilised to measure the rate of delivery of metabolic substrates (via cerebral blood flow i.e. concentrations of total-haemoglobin) and oxygen extraction from the blood (concentration of deoxy-haemoglobin) in the frontal cortex of the brain during cognitive tasks.

The ICa calculated from exhaled gas analysis will be utilised to quantify the overall 'energy' costs of performance of tasks in terms of oxygen uptake, carbon dioxide production, energy expenditure, and substrate (fat and carbohydrate) metabolism.

Cognitive tasks of differing levels of difficulty will be utilised with the hypothesis that energy expenditure parameters and blood flow/oxygen extraction will increase with rising task demands, and that any treatment related effect will be more evident under conditions of increased neural activity. The effects on the above mentioned parameters of two multivitamin/multimineral preparations (MMP) will be compared to placebo subsequent to single dose administration (acute) and following daily administration over an eight week period (chronic). The nutritional interventions are expected to improve nutritional status and thereby facilitate energy supply and metabolism and to have positive impact on the study parameters. The effects of the nutritional interventions on nutritional status will be evaluated by measuring the plasma/serum concentrations of a selected subset of analytes. It is hypothesized that the nutritional status at baseline and after eight week supplementation period will have an impact on metabolic substrate conversion, oxygen utilisation, cerebral blood flow and cognitive performance.

Conditions studied

Metabolic Processes

Keywords

cerebral blood flow
cognitive function
vitamins
energy expenditure
NIRS
Indirect calorimetry

In context

Lead sponsor

Northumbria University is the lead sponsor of 156 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years to 50 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy females aged 25 to 50 years.

Female subjects of childbearing potential must be using a medically acceptable form of birth control and have a negative pregnancy test at screening.
Subjects agree to abstain throughout the trial from intake of MMP or supplements containing CoQ10.
Body mass index (BMI) in the range of 18.50-34.99 kg/m2 (extremes included; including normal weight, overweight and class I obese subjects according to WHO BMI classification (WHO 2004)).
Subjects are, in the opinion of the investigator willing to participate in all scheduled visits, to adhere to the treatment plan, and other trial procedures according to the protocol.
Subjects accept to refrain from alcohol intake 24 hours and to fast 12 hours before the visits.
Subjects do not have any condition which may interfere with the subject's ability to perform assessments (i.e. colour blindness) 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.

Exclusion criteria

Exclusion Criteria:

Physical parameters (including vital signs, e.g., blood pressure, pulse rate, respiratory rate and body temperature) deviating from normal and with clinical relevance.

Acute infection at screening or randomization.
A history of, neurological or psychiatric diseases excluding anxiety or depression.
Current diagnosis of depression or anxiety.
A history or current diagnosis of diseases, for which use of MMP might be contraindicated or utilisation of MMP might be affected (e.g., iron accumulation, iron utilisation disorders, hypercalcemia, hypercalciuria, impaired renal function, hypervitaminosis A, hypervitaminosis D).
A history of significant head trauma.
Smoker (smoking within the last 3 months).
Excessive use of caffeine (> 500 mg caffeine per day) from all dietary sources.
History of migraines within the last five years.
Current intake of pharmaceuticals (with exception of oral contraceptives, or other routine medications to treat benign conditions, such as antibiotics to treat acne).
Habitual intake of MMP and dietary supplements within the last 4 weeks (defined as ≥3 consecutive days or ≥4 days in total per week).
Current or history of drug or alcohol abuse in the opinion of the investigator.
Current pregnancy or lactation.
Participation in another clinical trial within 30 days prior to screening.
Any condition which may interfere with the subject's ability to perform assessments (i.e. colour blindness).
Any history of hypersensitivity to the investigational medicinal product or its active or inactive constituents or any food allergy or intolerance.

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 106 participants (actual)

Study arms

Placebo comparator
Placebo
Matched placebo
Dietary Supplement: Placebo
Experimental
1RDA+CoQ10
Supradyn® (1RDA+CoQ10) containing vitamins and minerals at levels up to 100% of the 2008 European Union recommended dietary allowances (RDAs), plus 4.5 mg CoQ10 (1RDA+CoQ10).
Dietary Supplement: Supradyn® (1RDA+CoQ10)
Experimental
3RDA
Supradyn® (3RDA) containing vitamins and minerals at levels up to 300% of the 1990 European Union RDAs (3RDA).
Dietary Supplement: Supradyn® (3RDA)

Interventions

Dietary supplementSupradyn® (1RDA+CoQ10)
Dietary supplementSupradyn® (3RDA)
Dietary supplementPlacebo

What researchers measure

Primary outcomes

Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy)
Time frame: 1 hour post dose
Fat oxidation (Indirect calorimetry)
Time frame: 1 hour post dose
Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy)
Time frame: 1 hour post dose
Concentration change in total hemoglobin (Near Infrared Spectroscopy)
Time frame: 1 hour post dose
Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy)
Time frame: 56 days post dose
Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy)
Time frame: 56 days post dose
Concentration change in total hemoglobin (Near Infrared Spectroscopy)
Time frame: 56 days post dose
Carbohydrate oxidation (Indirect calorimetry)
Time frame: 1 hour post dose
Total energy expenditure (Indirect calorimetry)
Time frame: 1 hour post dose
Fat oxidation (Indirect calorimetry)
Time frame: 56 days post dose
Carbohydrate oxidation (Indirect calorimetry)
Time frame: 56 days post dose
Total energy expenditure (Indirect calorimetry)
Time frame: 56 days post dose

Secondary outcomes

Serial 3 subtractions accuracy (Computerised cognitive task)
Time frame: 1 hour post dose
Serial 3 subtractions accuracy (Computerised cognitive task)
Time frame: 56 days post dose
Serial 7 subtractions accuracy (Computerised cognitive task)
Time frame: 1 hour post dose
Serial 7 subtractions accuracy (Computerised cognitive task)
Time frame: 56 days post dose
Serial 17 subtractions accuracy (Computerised cognitive task)
Time frame: 1 hour post dose
Serial 17 subtractions accuracy (Computerised cognitive task)
Time frame: 56 days post dose
3-back task accuracy (Computerised cognitive task)
Time frame: 1 hour post dose
3-back task reaction time (Computerised cognitive task)
Time frame: 1 hour post dose
3-back task accuracy (Computerised cognitive task)
Time frame: 56 days post dose
3-back task reaction time (Computerised cognitive task)
Time frame: 56 days post dose
Stroop task accuracy (Computerised cognitive task)
Time frame: 1 hour post dose
Stroop task reaction time (Computerised cognitive task)
Time frame: 1 hour post dose
Stroop task accuracy (Computerised cognitive task)
Time frame: 56 days post dose
Stroop task reaction time (Computerised cognitive task)
Time frame: 56 days post dose
Subjective rating of task difficulty for Serial 3 subtractions (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subjective rating of task difficulty for Serial 7 substractions (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subjective rating of task difficulty for Serial 17 substractions (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subjective rating of task difficulty for 3 back task (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subjective rating of task difficulty for stroop task (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subjective rating of task difficulty for Serial 3 subtractions (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subjective rating of task difficulty for Serial 7 subtractions (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subjective rating of task difficulty for Serial 17 subtractions (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subjective rating of task difficulty for 3 back task (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subjective rating of task difficulty for stroop task (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subject ratings of energy levels (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subject ratings of energy levels (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subject ratings of calmness (Computerised Bond-Lader mood scales)
Time frame: 1 hour post dose
Subject ratings of calmness (Computerised Bond-Lader mood scales)
Time frame: 56 days post dose
Subject ratings of contentedness (Computerised Bond-Lader mood scales)
Time frame: 1 hour post dose
Subject ratings of contentedness (Computerised Bond-Lader mood scales)
Time frame: 56 days post dose
Subject ratings of alertness (Computerised Bond-Lader mood scales)
Time frame: 1 hour post dose
Subject ratings of alertness (Computerised Bond-Lader mood scales)
Time frame: 56 days post dose

Study locations

1 site

Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne And Wear NE1 8ST, United Kingdom

References and documents

Publications

Kennedy DO, Stevenson EJ, Jackson PA, Dunn S, Wishart K, Bieri G, Barella L, Carne A, Dodd FL, Robertson BC, Forster J, Haskell-Ramsay CF. Multivitamins and minerals modulate whole-body energy metabolism and cerebral blood-flow during cognitive task performance: a double-blind, randomised, placebo-controlled trial. Nutr Metab (Lond). 2016 Feb 11;13:11. doi: 10.1186/s12986-016-0071-4. eCollection 2016. PubMed 26870152 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02381964
Lead sponsor: Northumbria University
Collaborators: Bayer
Responsible party: David Kennedy (Professor David Kennedy, Northumbria University) — Principal investigator
First posted: Mar 6, 2015
Start date: Mar 2012
Primary completion: Feb 2013
Completion: Feb 2013
Last update: Mar 30, 2018

Study contacts

David O Kennedy, PhD

principal investigator · Northumbria University

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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