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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Leeds.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Welch's, Inc.
Information provided by:
University of Leeds
ClinicalTrials.gov Identifier:
NCT01411631
First received: June 7, 2011
Last updated: August 5, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Cognition
Dietary Supplement: Grape juice polyphenols

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children

Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • Change in Cognitive function & Driving Performance [ Time Frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm ] [ Designated as safety issue: No ]
    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.

  • Subjective Stress [ Time Frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Measured using visual analogue scales a regular intervals throughout the test day.


Estimated Enrollment: 24
Study Start Date: March 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411631

Locations
United Kingdom
University of Leeds, Institute of Psychological Sciences
Leeds, West Yorkshire, United Kingdom, LS29JT
Sponsors and Collaborators
University of Leeds
Welch's, Inc.
Investigators
Principal Investigator: Louise Dye, PhD (Professor) University of Leeds
  More Information

No publications provided

Responsible Party: Professor Louise Dye, University of Leeds
ClinicalTrials.gov Identifier: NCT01411631     History of Changes
Other Study ID Numbers: 11-0026
Study First Received: June 7, 2011
Last Updated: August 5, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Leeds:
Polyphenols
Cognition
Cognitive function
Driving performance
Stress

ClinicalTrials.gov processed this record on April 17, 2014