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

Cognition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411631
• Other study ID #: 11-0026
• Status: Completed
• Phase: N/A
• First received: June 7, 2011
• Last updated: May 21, 2014
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: May 2014
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cognition

Intervention

Dietary Supplement:
• Grape juice polyphenols
Participants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks.

Locations

Country	Name	City	State
United Kingdom	University of Leeds, Institute of Psychological Sciences	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	Welch's, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No