NCT01344551

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

3.9 years

First QC Date

April 27, 2011

Last Update Submit

February 20, 2013

Conditions

Neural Degeneration

Outcome Measures

Primary Outcomes (1)

  • Executive function - attention

    change from baseline to 2 hours

Secondary Outcomes (2)

  • Blood pressure

    change from baseline to 2 hours

  • Plasma flavanols

    change from baseline to 2 hours

Study Arms (2)

High Flavanol

ACTIVE COMPARATOR

High Flavanol cocoa drink containing 495mg cocoa

Dietary Supplement: Cocoa Drink

Low Flavanol

PLACEBO COMPARATOR

Low Flavanol cocoa drink (23mg)

Dietary Supplement: Cocoa Drink

Interventions

Cocoa DrinkDIETARY_SUPPLEMENT

High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients

High FlavanolLow Flavanol

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 62 - 75 years
  • A signed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG2 9AR, United Kingdom

Location

MeSH Terms

Conditions

Nerve Degeneration

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeremy Spencer, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

  • Laurie Butler, 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
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutritional Medicine

Study Record Dates

First Submitted

April 27, 2011

First Posted

April 29, 2011

Study Start

February 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 21, 2013

Record last verified: 2013-02

Locations

GB(1)