The Effects of Flavonoid Supplementation on Cognition and Neural Mechanisms in Healthy Older Adults

NCT03030053 | Unknown

• 1 other identifier: UREC1548_CoCo_ChronicTrial
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, randomised, controlled, parallel arm chronic intervention trial with healthy older adults will be conducted to determine the effect of a flavonoid-rich supplement on cognitive function, peripheral arterial health and brain mechanisms. It is predicted that chronic flavonoid supplementation will result in cognitive benefits and that these may be due to beneficial effects of flavonoids on vascular and brain function.

Conditions

Mental Processes

Keywords

Flavanols; Flavonoids; Polyphenols; Cognition; Aging

Outcome Measures

Primary Outcomes (2)

• Change in Cognitive Performance (0-24 weeks)

  Composite measure of global cognitive function (scores from different cognitive tasks will be standardised to allow an overall score of global cognitive function to be calculated)

  Change from baseline (pre intervention) to week 24 (post intervention)

• Change in Cognitive Performance (0-36 weeks)

  Composite measure of global cognitive function (scores from different cognitive tasks will be standardised to allow an overall score of global cognitive function to be calculated)

  Change from baseline (pre intervention) to week 36 (follow-up)

Secondary Outcomes (18)

• Change in Flow Mediated Dilatation (0-24 weeks)

  Change from baseline (pre intervention) to week 24 (post intervention)

• Change in Flow Mediated Dilatation (0-36 weeks)

  Change from baseline (pre intervention) to week 36 (follow-up)

• Change in cerebral blood flow (0-24 weeks)

  Change from baseline (pre intervention) to week 24 (post intervention)

• Change in cerebral blood flow (0-36 weeks)

  Change from baseline (pre intervention) to week 36 (post intervention)

• Change in brain activity (0-24 weeks)

  Change from baseline (pre intervention) to week 24 (post intervention)

Study Arms (2)

Active

EXPERIMENTAL

Cocoa-Flavanol Supplements: 3 capsules per day each containing 300mg (total dose of 900mg daily) for 24 weeks

Dietary Supplement: Cocoa-Flavanol Supplements

Control

PLACEBO COMPARATOR

Control Supplements: 0mg cocoa-flavanols per day for 24 weeks

Dietary Supplement: Control Supplements

Interventions

Cocoa-Flavanol Supplements DIETARY_SUPPLEMENT

3 capsules each containing 300mg cocoa flavanols (total daily dose of 900mg cocoa-flavanols).

Active

Control Supplements DIETARY_SUPPLEMENT

3 capsules each containing 0mg cocoa-flavanols

Control

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 60-75 years
• English as primary language, able to understand the study information sheet, follow instructions in English and give informed consent
• Non-smokers
• Alcohol consumption should be within the current National Health Service (NHS) recommendation - women: ≤21 units per week (max 3 per day), 1 large 250mL glass of wine (Alcohol By Volume 12%) is 3 units; men: ≤ 28 units per week (max 4 per day), 1 pint of strong lager/beer/cider (Alcohol By Volume 5.2%) is 3 units
• BP \<150/90 (determined at screening)
• BMI \<30 (determined at screening)
• Full blood count parameters within the normal range, specifically:
• Haemoglobin to check for anaemia (\>12.5 g/dL for males and \>11.5 g/dL for females)
• Total white cell count (3.6-11.0 x109/L)
• Differential count:
• Neutrophils (1.8 - 7.5 x109/L)
• Lymphocytes (1.0 - 4.0 x109/L)
• Monocytes (0.2 - 0.8 x109/L)
• Eosinophils (0.1 - 0.4 x109/L)
• Basophils (0.02 - 0.1 x109/L)

You may not qualify if:

• General global cognitive impairment (Mini Mental State Examination score \< 24)
• Un-corrected vision or hearing problems
• Speech or communication difficulties
• Currently suffering from depression (Brief Symptom Inventory score of ≥ 11)
• Diagnosed with any learning difficulty such as Dyslexia or Dyspraxia
• Sensitive/allergic to the intervention or any of the study foods
• Suffering from any form of clinically diagnosed disease, including:
• Major mental illness (current or previous episode with hospitalization)
• Chronic fatigue syndrome
• Liver disease
• Diabetes mellitus
• Heart disease or myocardial infarction
• Taking blood pressure medication, anticoagulants, anti-platelet medication or antidepressants
• On a weight reducing dietary regimen or taking any dietary supplements (including dietary fatty acids), unless willing to temporarily refrain from taking dietary supplements for the duration of the study
• Subjects consuming more than seven portions of fruit and vegetables a day

Sponsors & Collaborators

• University of Reading: lead
• Mars, Inc.: collaborator
• Biotechnology and Biological Sciences Research Council: collaborator

Study Sites (1)

Hugh Sinclair Unit of Human Nutrition, University of Reading

Reading, Berkshire, RG6 5SG, United Kingdom

Location

Study Officials

• Jeremy PE Spencer, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutritional Medicine

Study Record Dates

• First Submitted: May 7, 2016
• First Posted: January 24, 2017
• Study Start: February 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 24, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)