NCT03030053

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

Mechanistic Assessment of the Acute and Chronic Cognitive Effects of Flavanol/Anthocyanin Intervention in Humans - Chronic Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Reading · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

There has recently been an increasing interest in the potential of flavonoids, plant derived compounds found in foods such as fruit and vegetables, to improve cognitive function. Research suggests that flavonoids improve memory and learning, possibly as a result of their anti-inflammatory and neuroprotective effects, for example by increasing cerebral blood flow (CBF), protecting vulnerable neurons, or by stimulating neuronal function and growth. The proposed research will involve a parallel design chronic dietary supplementation trial using a flavonoid-supplement and a matched control containing no flavonoids, to investigate long-term changes in cognitive performance. To understand the neural mechanisms behind potential changes in cognitive performance, resting cerebral blood flow (CBF), blood-oxygen level dependent (BOLD) response during two sensitive tests of cognitive performance, and structural brain changes will be measured in a group of healthy elderly adults (N=70, age range 60-75 years) using magnetic resonance imaging (MRI). Additionally, peripheral vascular health will be measured using flow mediated dilatation (FMD), and bioavailability of flavonoid monomers and metabolites will be determined through analysis of plasma and urine samples. Biomarkers in the blood associated with vascular health and neural functioning as well as markers of interest in relation to the possible mechanisms of action of flavonoids will also be measured. All endpoints will be acquired before and after a 24-week chronic supplementation of either a high flavonoid supplementation or a control product, consumed in addition to participants' normal diet. Measures will also be taken following a 12-week post-intervention washout period in order to investigate whether any beneficial effects are sustained following cessation of supplementation.

Conditions

• Mental Processes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cocoa-Flavanol Supplements	3 capsules each containing 300mg cocoa flavanols (total daily dose of 900mg cocoa-flavanols).
DIETARY_SUPPLEMENT	Control Supplements	3 capsules each containing 0mg cocoa-flavanols

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-01-24
• Last updated: 2018-05-24

Locations

1 site across 1 country: United Kingdom