A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children
- Conditions
- Cognition
- Interventions
- Dietary Supplement: Grape juice polyphenols
- Registration Number
- NCT01411631
- Lead Sponsor
- University of Leeds
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Grape juice Grape juice polyphenols Participants will drink 100% concord grape juice daily for 12 weeks Placebo drink Grape juice polyphenols 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.
- Primary Outcome Measures
Name Time Method Change in Cognitive function & Driving Performance 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.
- Secondary Outcome Measures
Name Time Method Blood Pressure 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.
Subjective ratings of appetite, mood, mental alertness, and concentration 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.
Subjective Stress 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.
Trial Locations
- Locations (1)
University of Leeds, Institute of Psychological Sciences
🇬🇧Leeds, West Yorkshire, United Kingdom