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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cognition

Intervention / Treatment
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* Dietary Supplement: Grape juice polyphenols


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Grape juice<br>Participants will drink 100% concord grape juice daily for 12 weeks | Dietary Supplement: Grape juice polyphenols<br>* Participants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks.<br>|
| Placebo Comparator: Placebo drink<br>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<br>* Participants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive function & Driving Performance | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyphenols, Cognition, Cognitive function, Driving performance, Stress