A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children

May 21, 2014 updated by: Prof Louise Dye, University of Leeds

There is some evidence that polyphenols can affect cognitive function. Therefore, consumption of polyphenols has the potential to prevent cognitive impairment or even enhance cognitive performance. The objective of this study is to investigate the effect of polyphenol consumption served in the form of Concord Grape Juice (CGJ) on cognitive performance and driving performance in Mums.

The study design will be a repeated measures, double-blind, randomised, placebo controlled, crossover study. There will be 2 conditions; CGJ and a placebo drink. 20 participants will undergo two 12 week dietary interventions which will entail daily consumption of a 12oz serving of CGJ or placebo in a counterbalanced manner. There will be a 4 week washout period between conditions. At baseline, 6, and 12 weeks of each 12-week treatment arm cognitive performance and driving performance will be assessed (using the driving simulator at the Institute for Transport Studies). CGJ is a common ingredient in commercially available products.

Mums will be defined as mothers of pre-teen children (aged under 13 years) who are aged 40-50. This population generally have hectic and stressful lifestyles and therefore there is potential for this population to receive cognitive benefit from polyphenol consumption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS29JT
        • University of Leeds, Institute of Psychological Sciences

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

40 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • BMI within normal/overweight range (18 - 29 kg/m2)
  • Non-smokers or given up more than 6 months ago
  • Working 80% of a full time week (at least 30 hours/week)
  • Ability to adequately understand verbal and written information in English
  • Full Driving Licence held for at least 5 years
  • Mothers of pre-teen children (must have child aged <13 years)
  • Willing to abstain from drinking red wine and dark fruit juices (e.g. other grape juices, cranberry, raspberry and pomegranate juices) during the study

Exclusion Criteria:

  • Menopausal
  • diabetes or known impaired glucose tolerance
  • taking any regular medication e.g. for hypertension
  • Food allergies to ingredients and food colouring of the drinks to be consumed within the study
  • Night shift work
  • Pregnant or planning a pregnancy within the next year
  • Having been pregnant or lactating within the previous 6 months
  • Vegetarian
  • No history of, or current eating disorders
  • Epilepsy (driving SIM exclusion criterion)
  • Claustrophobia (driving SIM exclusion criterion)

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Grape juice
Participants will drink 100% concord grape juice daily for 12 weeks
Dietary supplement: Grape juice polyphenols
Participants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks.
Placebo Comparator: Placebo drink
Participants will drink the placebo for 12 weeks. The placebo will be equicaloric and matched on appearance, taste, volume and macronutrient composition to the grape juice drink.
Dietary supplement: Grape juice polyphenols
Participants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive function & Driving Performance
Time Frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Cogntive function will be assessed with a battery of cognitive tests, including tests of memory, problem solving skills, concentration, and attention. Driving performance will be assessed using a driving simulator.
Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Blood pressure measures will be taken over a period before, during and after the driving tasks using an ambulatory blood pressure monitor. An Omron M7 ambulatory blood pressure monitor will be used and can be worn during the driving task.
Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Subjective Stress
Time Frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
The sample will be characterised in terms of their psychological stress using the Perceived Stress Scale (PSS, Cohen et al., 1983) the Cook-Medley Hostility Scale (Cook & Medley, 1954), and the Spielberger STAI (Spielberger, 1983) administeredat screening. The PSS and the Spielberger MSTAI will also be administered on each test day.
Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Subjective ratings of appetite, mood, mental alertness, and concentration
Time Frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Measured using visual analogue scales a regular intervals throughout the test day.
Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm

Collaborators and Investigators

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

Sponsor

University of Leeds

Collaborators

Welch's, Inc.

Investigators

  • Principal Investigator: Louise Dye, PhD (Professor), University of Leeds

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

March 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-0026

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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