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

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ClinicalTrials.gov Identifier: NCT01411631
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
Welch's, Inc.
Information provided by (Responsible Party):
Prof Louise Dye, University of Leeds

Tracking Information
First Submitted Date  ICMJE June 7, 2011
First Posted Date  ICMJE August 8, 2011
Last Update Posted Date May 22, 2014
Study Start Date  ICMJE March 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01411631 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2011)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children
Official Title  ICMJE A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Cognition
Intervention  ICMJE Dietary Supplement: Grape juice polyphenols
Participants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks.
Study Arms  ICMJE
  • Active Comparator: Grape juice
    Participants will drink 100% concord grape juice daily for 12 weeks
    Intervention: Dietary Supplement: Grape juice polyphenols
  • Placebo Comparator: Placebo drink
    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.
    Intervention: Dietary Supplement: Grape juice polyphenols
Publications * Lamport DJ, Lawton CL, Merat N, Jamson H, Myrissa K, Hofman D, Chadwick HK, Quadt F, Wightman JD, Dye L. Concord grape juice, cognitive function, and driving performance: a 12-wk, placebo-controlled, randomized crossover trial in mothers of preteen children. Am J Clin Nutr. 2016 Mar;103(3):775-83. doi: 10.3945/ajcn.115.114553. Epub 2016 Feb 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2014)
25
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2011)
24
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01411631
Other Study ID Numbers  ICMJE 11-0026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Louise Dye, University of Leeds
Study Sponsor  ICMJE University of Leeds
Collaborators  ICMJE Welch's, Inc.
Investigators  ICMJE
Principal Investigator: Louise Dye, PhD (Professor) University of Leeds
PRS Account University of Leeds
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP