Clinical trial NCT01411631: A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children
Official title: A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Keywords: Polyphenols
Cognition
Cognitive function
Driving performance
Stress
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Welch's, Inc.
First posted: 2011-08-08
Enrollment: 25
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Cognitive function & Driving Performance
timeFrame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Secondary outcomes:
measure: Blood Pressure
timeFrame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
measure: Subjective Stress
timeFrame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
measure: Subjective ratings of appetite, mood, mental alertness, and concentration
timeFrame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds, Institute of Psychological Sciences
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Louise Dye, PhD (Professor)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.