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

NCT02381964 | Completed

• 1 other identifier: 9L4
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Processes

Keywords

cerebral blood flow; cognitive function; vitamins; energy expenditure; NIRS; Indirect calorimetry

Outcome Measures

Primary Outcomes (12)

• Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy)

  1 hour post dose

• Fat oxidation (Indirect calorimetry)

  1 hour post dose

• Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy)

  1 hour post dose

• Concentration change in total hemoglobin (Near Infrared Spectroscopy)

  1 hour post dose

• Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy)

  56 days post dose

• Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy)

  56 days post dose

• Concentration change in total hemoglobin (Near Infrared Spectroscopy)

  56 days post dose

• Carbohydrate oxidation (Indirect calorimetry)

  1 hour post dose

• Total energy expenditure (Indirect calorimetry)

  1 hour post dose

• Fat oxidation (Indirect calorimetry)

  56 days post dose

• Carbohydrate oxidation (Indirect calorimetry)

  56 days post dose

• Total energy expenditure (Indirect calorimetry)

  56 days post dose

Secondary Outcomes (32)

• Serial 3 subtractions accuracy (Computerised cognitive task)

  1 hour post dose

• Serial 3 subtractions accuracy (Computerised cognitive task)

  56 days post dose

• Serial 7 subtractions accuracy (Computerised cognitive task)

  1 hour post dose

• Serial 7 subtractions accuracy (Computerised cognitive task)

  56 days post dose

• Serial 17 subtractions accuracy (Computerised cognitive task)

  1 hour post dose

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Matched placebo

Dietary Supplement: Placebo

1RDA+CoQ10

EXPERIMENTAL

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)

3RDA

EXPERIMENTAL

Supradyn® (3RDA) containing vitamins and minerals at levels up to 300% of the 1990 European Union RDAs (3RDA).

Dietary Supplement: Supradyn® (3RDA)

Interventions

Supradyn® (1RDA+CoQ10) DIETARY_SUPPLEMENT

1RDA+CoQ10

Supradyn® (3RDA) DIETARY_SUPPLEMENT

3RDA

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Northumbria University: lead
• Bayer: collaborator

Study Sites (1)

Brain performance and nutrition research centre, Northumbria university

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26870152 DERIVED

MeSH Terms

Interventions

Supradyn

Study Officials

• David O Kennedy, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor David Kennedy

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: March 6, 2015
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

GB (1)