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

March 28, 2018 updated by: David Kennedy, Northumbria University

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.

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.

Study Overview

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

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: David O Kennedy, PhD, Northumbria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

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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