A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Cognitive function & Driving Performance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Grape juice
Participants will drink 100% concord grape juice daily for 12 weeks
干预措施: Grape juice polyphenols (Dietary Supplement)
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.
干预措施: Grape juice polyphenols (Dietary Supplement)
结局指标
主要结局
Change in Cognitive function & Driving Performance
时间窗: 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.
次要结局
- Blood Pressure(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)
- Subjective Stress(Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm)
研究者
Prof Louise Dye
Professor
University of Leeds