A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
August 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMay 22, 2014
May 1, 2014
1.3 years
June 7, 2011
May 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Blood Pressure
Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Subjective Stress
Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Subjective ratings of appetite, mood, mental alertness, and concentration
Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Study Arms (2)
Grape juice
ACTIVE COMPARATORParticipants will drink 100% concord grape juice daily for 12 weeks
Placebo drink
PLACEBO COMPARATORParticipants 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.
Interventions
Participants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leedslead
- Welch's, Inc.collaborator
Study Sites (1)
University of Leeds, Institute of Psychological Sciences
Leeds, West Yorkshire, LS29JT, United Kingdom
Related Publications (1)
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.
PMID: 26864371DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Louise Dye, PhD (Professor)
University of Leeds
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 7, 2011
First Posted
August 8, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
May 22, 2014
Record last verified: 2014-05