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Effects of Cocoa Flavanols on Human Cognitive Function

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University of Reading

Status

Completed

Conditions

Neural Degeneration

Treatments

Dietary Supplement: Cocoa Drink

Study type

Interventional

Funder types

Other

Identifiers

NCT01344551
UReading-2011-02

Details and patient eligibility

About

To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function in healthy older adults.

Full description

This is a randomised controlled double blind cross over study investigating the acute effects of high flavanol (495mg) compared to low flavanol (23mg)cocoa drink on cognitive function in a healthy older adult population (n=60). The primary outcome measure of this study is to determine the effects of the flavanol intervention on cognitive measures of executive function and attention and the secondary measures of blood pressure and to determine whether any observed effects are paralleled by plasma flavanol levels.

Enrollment

63 patients

Sex

All

Ages

60 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged 62 - 75 years
  • A signed consent form

Exclusion criteria

  • Blood pressure > 160/90 mmHg
  • Haemoglobin (anaemia marker) < 125 g/l
  • Gamma GT (liver enzymes) > 80 IU/l
  • Had suffered a myocardial infarction or stroke in the previous 12 months
  • Suffers from any gastrointestinal/stomach disorder
  • Suffers from any blood-clotting disorder
  • On medication for hypertension
  • Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
  • Depression or major mental illness
  • Any dietary restrictions or on a weight reducing diet
  • Drinking more than 21 units per week
  • On any medication affecting blood clotting
  • Smoking
  • Vegans

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

63 participants in 2 patient groups, including a placebo group

High Flavanol
Active Comparator group
Description:
High Flavanol cocoa drink containing 495mg cocoa
Treatment:
Dietary Supplement: Cocoa Drink
Low Flavanol
Placebo Comparator group
Description:
Low Flavanol cocoa drink (23mg)
Treatment:
Dietary Supplement: Cocoa Drink

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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