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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01411631
Enrollment
25
Registered
2011-08-08
Start date
2011-03-31
Completion date
2012-06-30
Last updated
2014-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition

Keywords

Polyphenols, Cognition, Cognitive function, Driving performance, Stress

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.

Interventions

DIETARY_SUPPLEMENTGrape juice polyphenols

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

Sponsors

Welch's, Inc.
CollaboratorINDUSTRY
University of Leeds
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 50 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Cognitive function & Driving PerformanceMeasured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental armCogntive 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

MeasureTime frameDescription
Blood PressureMeasured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental armBlood 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 StressMeasured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental armThe 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 concentrationMeasured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental armMeasured using visual analogue scales a regular intervals throughout the test day.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026