- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02381964
The Effects of Differing Cognitive Task Demands on Whole-body Energy Metabolism and Cerebral Blood-flow: Modulation by Multivitamins/Minerals and Coenzyme Q10
Pilot, Randomized, Placebo-controlled, Double-blind, 3-arm Parallel Groups Trial in Healthy Females to Assess Cerebral Haemodynamics and Energy Expenditure During Cognitive Performance After Supplementation With Two Different Multivitamin / Mineral Preparations.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tyne And Wear
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Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST
- Brain performance and nutrition research centre, Northumbria university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Matched 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).
|
|
Experimental: 3RDA
Supradyn® (3RDA) containing vitamins and minerals at levels up to 300% of the 1990 European Union RDAs (3RDA).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Fat oxidation (Indirect calorimetry)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Concentration change in total hemoglobin (Near Infrared Spectroscopy)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy)
Time Frame: 56 days post dose
|
56 days post dose
|
Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy)
Time Frame: 56 days post dose
|
56 days post dose
|
Concentration change in total hemoglobin (Near Infrared Spectroscopy)
Time Frame: 56 days post dose
|
56 days post dose
|
Carbohydrate oxidation (Indirect calorimetry)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Total energy expenditure (Indirect calorimetry)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Fat oxidation (Indirect calorimetry)
Time Frame: 56 days post dose
|
56 days post dose
|
Carbohydrate oxidation (Indirect calorimetry)
Time Frame: 56 days post dose
|
56 days post dose
|
Total energy expenditure (Indirect calorimetry)
Time Frame: 56 days post dose
|
56 days post dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serial 3 subtractions accuracy (Computerised cognitive task)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Serial 3 subtractions accuracy (Computerised cognitive task)
Time Frame: 56 days post dose
|
56 days post dose
|
Serial 7 subtractions accuracy (Computerised cognitive task)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Serial 7 subtractions accuracy (Computerised cognitive task)
Time Frame: 56 days post dose
|
56 days post dose
|
Serial 17 subtractions accuracy (Computerised cognitive task)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Serial 17 subtractions accuracy (Computerised cognitive task)
Time Frame: 56 days post dose
|
56 days post dose
|
3-back task accuracy (Computerised cognitive task)
Time Frame: 1 hour post dose
|
1 hour post dose
|
3-back task reaction time (Computerised cognitive task)
Time Frame: 1 hour post dose
|
1 hour post dose
|
3-back task accuracy (Computerised cognitive task)
Time Frame: 56 days post dose
|
56 days post dose
|
3-back task reaction time (Computerised cognitive task)
Time Frame: 56 days post dose
|
56 days post dose
|
Stroop task accuracy (Computerised cognitive task)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Stroop task reaction time (Computerised cognitive task)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Stroop task accuracy (Computerised cognitive task)
Time Frame: 56 days post dose
|
56 days post dose
|
Stroop task reaction time (Computerised cognitive task)
Time Frame: 56 days post dose
|
56 days post dose
|
Subjective rating of task difficulty for Serial 3 subtractions (Computerised Visual Analogue Scale)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Subjective rating of task difficulty for Serial 7 substractions (Computerised Visual Analogue Scale)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Subjective rating of task difficulty for Serial 17 substractions (Computerised Visual Analogue Scale)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Subjective rating of task difficulty for 3 back task (Computerised Visual Analogue Scale)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Subjective rating of task difficulty for stroop task (Computerised Visual Analogue Scale)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Subjective rating of task difficulty for Serial 3 subtractions (Computerised Visual Analogue Scale)
Time Frame: 56 days post dose
|
56 days post dose
|
Subjective rating of task difficulty for Serial 7 subtractions (Computerised Visual Analogue Scale)
Time Frame: 56 days post dose
|
56 days post dose
|
Subjective rating of task difficulty for Serial 17 subtractions (Computerised Visual Analogue Scale)
Time Frame: 56 days post dose
|
56 days post dose
|
Subjective rating of task difficulty for 3 back task (Computerised Visual Analogue Scale)
Time Frame: 56 days post dose
|
56 days post dose
|
Subjective rating of task difficulty for stroop task (Computerised Visual Analogue Scale)
Time Frame: 56 days post dose
|
56 days post dose
|
Subject ratings of energy levels (Computerised Visual Analogue Scale)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Subject ratings of energy levels (Computerised Visual Analogue Scale)
Time Frame: 56 days post dose
|
56 days post dose
|
Subject ratings of calmness (Computerised Bond-Lader mood scales)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Subject ratings of calmness (Computerised Bond-Lader mood scales)
Time Frame: 56 days post dose
|
56 days post dose
|
Subject ratings of contentedness (Computerised Bond-Lader mood scales)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Subject ratings of contentedness (Computerised Bond-Lader mood scales)
Time Frame: 56 days post dose
|
56 days post dose
|
Subject ratings of alertness (Computerised Bond-Lader mood scales)
Time Frame: 1 hour post dose
|
1 hour post dose
|
Subject ratings of alertness (Computerised Bond-Lader mood scales)
Time Frame: 56 days post dose
|
56 days post dose
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David O Kennedy, PhD, Northumbria University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9L4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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