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

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 May 22, 2013