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

University of Leeds

Status: Completed

Conditions: Cognition

Treatments: Dietary Supplement: Grape juice polyphenols

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01411631

11-0026

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Female

Ages: 40 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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25 participants in 2 patient groups, including a placebo group

Grape juice

Active Comparator group

Description:

Participants will drink 100% concord grape juice daily for 12 weeks

Treatment:

Dietary Supplement: Grape juice polyphenols

Placebo drink

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Grape juice polyphenols