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Completed

NCT Number: NCT01411631

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

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.

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Key information

Conditions

Cognition

Age range

40 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Leeds, Institute of Psychological Sciences

Leeds, West Yorkshire, LS29JT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Grape juice polyphenols

Dietary Supplement

Participants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks.

Primary outcomes

  1. Change in Cognitive function & Driving Performance

    Time frame: 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 outcomes

  1. Blood Pressure

    Time frame: 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.

  2. Subjective Stress

    Time frame: 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.

  3. 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

    Measured using visual analogue scales a regular intervals throughout the test day.

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • Welch's, Inc.

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 8, 2011
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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