Effect of Polyphenol-rich Cocoa Products on Cognitive Function

March 26, 2023 updated by: Ruth Ashaye, Queen Margaret University

Consumption of Polyphenol Rich Cocoa Products Over 8 Weeks and Its Effect on Cognitive Function in Individuals in Their 5th Decade of Life.

This project aims to investigate whether consumption of cocoa polyphenols has an impact on cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a result of an improvement in risk factors associated with cognitive decline in ageing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy cognitive ageing is an important aspect of the ageing process as it involves larger numbers of people compared to those who have already been diagnosed with conditions on the dementia spectrum (Deary et al, 2009). Hence, an active effort looking at potential lifestyle factor modification interventions to help maintain cognitive well-being are warranted.

With an ageing population, the prevalence of cognitive syndromes such as Alzheimer's disease and Parkinson's disease increases (Vauzour, 2012). Nutritional interventions can play a role in successful ageing by helping to delay the onset of age-related conditions (Hendrickx, McEwen & van der Ouderaa, 2005; Brown, Riby & Reay, 2009; Monti, Moulton & Cohen, 2015). Studies have investigated the potential role of polyphenols as part of a neuroprotective lifestyle. Mouse model studies have looked at varying polyphenol sources such as tea (Haque et al., 2006; Kaur et al., 2008), blueberry (Shukitt-Hale et al., 2015; Williams et al., 2008), Gingko Biloba (Shif et al., 2008) and cocoa (Bisson et al., 2008) to mention a few.

Ageing and neurodegenerative diseases are caused by neuronal death which in turn can be triggered by neurotoxins, neuroinflammation and specific genetic mutations (Bishop, Lu & Yankner, 2010). Dietary polyphenols have been observed to provide neuroprotection against cellular alteration by modulating the neuronal function against endogenous neurotoxins and inhibition of glial induced neuroinflammation (Vauzour, 2012).

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males & Females aged 50-60years of age with normal or corrected to normal vision
  • BMI cut off points of ≥18.5 to ≤29.9 kg/m2
  • Waist circumference smaller than 102cm for males & smaller than 88cm for women
  • Blood pressure of ≥ 90 over 60 and ≤ 120 over 80
  • MoCA test score ≥ 26

Exclusion Criteria:

  • Allergies to cocoa or any other ingredients commonly found in cocoa confectionary eg: milk, nuts, soya
  • Smoker
  • Women who are new or expecting mothers, maybe or are currently pregnant and/or breastfeeding
  • Taking medications for chronic conditions including (but not limited to) diabetes, heart disease, hypertension
  • No previous history of stroke, brain trauma and other head-related injuries
  • No diagnosis of depression and/or anxiety
  • No previous cancer diagnosis
  • Taking antibiotics
  • Taking steroids and non-steroidal anti-inflammatory drugs (NSAIDS)
  • Women on Hormone Replacement Therapy (HRT)
  • Taking medication that can cause drowsiness or affect cognitive functioning
  • Taking polyphenol supplements including (but not limited to) green tea extract, acai berry extract
  • Taking soy/a supplements
  • History of alcohol misuse
  • Fear of needles and/or fainting when blood is taken

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Solid Matrix - Intervention

Dietary Supplement: polyphenol rich chocolate bar

17.5g of commercially available dark chocolate will be consumed daily for 8 weeks
Dietary supplement: polyphenol rich chocolate bar
High polyphenol content chocolate bar. Each participant will consume 581.4mg of polyphenols
Active Comparator: Powder Matrix - Intervention

Dietary Supplement: polyphenol rich cocoa powder

6g of commercially available cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks
Dietary supplement: polyphenol rich cocoa powder
High polyphenol content cocoa powder. Each participant will consume 6g containing 554mg of polyphenols
Placebo Comparator: Solid Matrix Intervention - Placebo

Dietary Supplement: low polyphenol chocolate

17.5g of commercially available, nutritionally similar, dark chocolate will be consumed daily for 8 weeks
Dietary supplement: low polyphenol content chocolate bar
Low polyphenol content matched chocolate bar. Each participant will consume 198.5mg of polyphenols
Placebo Comparator: Powder Matrix - Placebo

Dietary Supplement: nutritionally similar low polyphenol cocoa powder

6g of commercially available, nutritionally similar, cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks
Dietary supplement: low polyphenol content cocoa powder
Low polyphenol content cocoa powder. Each participant will consume 6g containing 191.2mg of polyphenols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Function
Time Frame: 8 weeks
A test battery consisting of 7 tests will be used to investigate the role of cocoa flavanols on cognitive function in the cohort.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: 8 weeks
8 weeks
Pulse Wave Analysis
Time Frame: 8 weeks
Carotid to femoral Pulse Wave Velocity (PWV) and Augmentation Index (Aix) will be measured using a Vicorder.
8 weeks
Glycated Haemoglobin (HbA1c)
Time Frame: 8 weeks
8 weeks
Weight (Kg)
Time Frame: 8 weeks
To allow for BMI measurement
8 weeks
Height (m)
Time Frame: 8 weeks
To allow for BMI measurement
8 weeks
Body Fat Percentage
Time Frame: 8 weeks
8 weeks
Energy intakes (Kj)
Time Frame: 8 weeks
8 weeks
Flavonoid intakes (mg)
Time Frame: 8 Weeks
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Margaret University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2017

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 26, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QueenMUra

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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