A Randomized Controlled Trial to Investigate the Cognitive, Vascular, Neural and Biochemical Effects of Acute Pistachio Intervention in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Delayed recall (Rey Auditory Verbal Learning Task)
研究概览
简要总结
This study aims to investigate the effect of a breakfast meal containing varying serving sizes (doses) of pistachio nuts on cognitive function throughout the course of the day in healthy ageing adults aged 65-80.
详细描述
This crossover RCT investigates the acute postprandial effect (over a 6-hour period) of a breakfast meal containing varying serving sizes (doses) of pistachio nuts on the cognitive behaviour in healthy adults aged 65-80 years old. The study will also assess markers of inflammation and brain health by taking blood samples, and explore brain function (EEG) and blood flow (FMD) to understand how pistachio nuts may positively influence cognitive health. The study will involve a screening visit and four testing visits, with a week interval between each. On the evening prior to each test visit, participants are asked not to consume any food or drinks expect water, including tea/coffee and alcohol, after 8.30pm, and on the morning of test visits to only consume one slice of buttered white toast and a glass of water prior to attending the visit. During the four testing visits, cognitive and mood battery tests will be taken at baseline and then at 2-, 4- and 6-hour intervals following the consumption of the intervention meal. Blood draws are taken at the end of the day. For the subset of participants taking part in FMD, this will be measured at baseline, 2, 4 and 6 hours prior to cognitive testing. For those taking part in EEG, this data will be collected at 6 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 - 80 years old
- •Fruit & veg intake less than or equal to 4 servings per day
- •Not regularly consuming more than 3 servings of fish per week
- •Adequate English language and visual & auditory acuity to perform the cognitive tasks
- •Normal BMI for age
- •Normal MMSE performance between 26-30
排除标准
- •Being diagnosed with psychological or psychiatric disorders
- •ADHD or dyslexia
- •Any food allergy or intolerance
- •Use of medications and dietary supplements that may impact study results
- •Antibiotic use within the last 3 months
- •Adherence to vegan or vegetarian diets, or other specific diets that may impact study outcomes
- •Being diagnosed with cardiometabolic disease (including type II diabetes and cardiovascular disease), or suffer from untreated hypertension or thrombosis related disorders
- •Taking blood thinners
研究组 & 干预措施
Placebo
Macronutrient-matched placebo breakfast meal
干预措施: Placebo (Dietary Supplement)
0.5 servings of pistachio
0.5 servings of pistachio (15g) administered in breakfast meal
干预措施: 0.5 serving of pistachios (Dietary Supplement)
1 serving of pistachio
1 serving of pistachio (30g) administered in breakfast meal
干预措施: 1 serving of pistachios (Dietary Supplement)
2 servings of pistachio
2 servings of pistachio (60g) administered in breakfast meal
干预措施: 2 servings of pistachios (Dietary Supplement)
结局指标
主要结局
Delayed recall (Rey Auditory Verbal Learning Task)
时间窗: 6 hours
The RAVLT is a verbal learning task that presents participants with 15 words (list A) 5 times, giving participants one minute after each presentation to recall as many words as they can from the list. After 5 presentations, a new list (list B) is presented and recalled, and finally participants are asked (without hearing list A again) to recall as many words as they can from list A. After a 30 minute period, participants are asked to think back to the task and recall as many words as possible from list A only, providing a measure of delayed recall.
Delayed recall (Rey Auditory Verbal Learning Task)
时间窗: Baseline
The RAVLT is a verbal learning task that presents participants with 15 words (list A) 5 times, giving participants one minute after each presentation to recall as many words as they can from the list. After 5 presentations, a new list (list B) is presented and recalled, and finally participants are asked (without hearing list A again) to recall as many words as they can from list A. After a 30 minute period, participants are asked to think back to the task and recall as many words as possible from list A only, providing a measure of delayed recall.
Delayed recall (Rey Auditory Verbal Learning Task)
时间窗: 2 hours
The RAVLT is a verbal learning task that presents participants with 15 words (list A) 5 times, giving participants one minute after each presentation to recall as many words as they can from the list. After 5 presentations, a new list (list B) is presented and recalled, and finally participants are asked (without hearing list A again) to recall as many words as they can from list A. After a 30 minute period, participants are asked to think back to the task and recall as many words as possible from list A only, providing a measure of delayed recall.
Delayed recall (Rey Auditory Verbal Learning Task)
时间窗: 4 hours
The RAVLT is a verbal learning task that presents participants with 15 words (list A) 5 times, giving participants one minute after each presentation to recall as many words as they can from the list. After 5 presentations, a new list (list B) is presented and recalled, and finally participants are asked (without hearing list A again) to recall as many words as they can from list A. After a 30 minute period, participants are asked to think back to the task and recall as many words as possible from list A only, providing a measure of delayed recall.
次要结局
- Blood markers(6 hours)
- Rate of learning (Rey Auditory Verbal Learning Task)(6 hours)
- Word recognition (Rey Auditory Verbal Learning Task)(6 hours)
- Modified Attention Network Task (MANT)(6 hours)
- Task Switching Task(6 hours)
- Corsi Block Tapping Task(6 hours)
- N-back task(6 hours)
- EEG (ERPs & PSD)(6 hours)
- Flow mediated dilation (FMD)(6 hours)
- Raven's Progressive Matrices(Baseline)
- Epic-Norfolk Food Frequency Questionnaire(Baseline)
- Blood pressure(6 hours)
- Rate of learning (Rey Auditory Verbal Learning Task)(Baseline)
- Rate of learning (Rey Auditory Verbal Learning Task)(2 hours)
- Rate of learning (Rey Auditory Verbal Learning Task)(4 hours)
- Word recognition (Rey Auditory Verbal Learning Task)(Baseline)
- Word recognition (Rey Auditory Verbal Learning Task)(2 hours)
- Word recognition (Rey Auditory Verbal Learning Task)(4 hours)
- Modified Attention Network Task (MANT)(Baseline)
- Modified Attention Network Task (MANT)(2 hours)
- Modified Attention Network Task (MANT)(4 hours)
- Task Switching Task(Baseline)
- Task Switching Task(2 hours)
- Flow mediated dilation (FMD)(2 hours)
- Task Switching Task(4 hours)
- Corsi Block Tapping Task(Baseline)
- Corsi Block Tapping Task(2 hours)
- Corsi Block Tapping Task(4 hours)
- N-back task(Baseline)
- N-back task(2 hours)
- N-back task(4 hours)
- Flow mediated dilation (FMD)(Baseline)
- Flow mediated dilation (FMD)(4 hours)
- Blood pressure(Baseline)
- Blood pressure(2 hours)
- Blood pressure(4 hours)
研究者
Prof Claire Williams
Professor
University of Reading