Investigating the Cognitive, Vascular, and Metabolic Benefits of a Vitamin- and Mineral-Enhanced Haskap Berry Dietary Supplement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 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 postprandial (2h) and longer term (4 week) effects of a haskap berry supplement on cognitive, vascular, and metabolic function in healthy ageing adults aged 50+.
详细描述
This project aims to investigate the acute benefits (during the immediate post prandial period up to 2 hours) and chronic benefits (following 4 weeks daily supplementation) of a vitamin- and mineral-enhanced haskap berry supplement made from freeze-dried, powdered haskap berries. The main objective of this study is to trial the product in older adults aged 50+ to determine any cognitive, metabolic, or cardiovascular benefits over and above haskap powder alone or a placebo powder. The study will involve a screening visit and two testing visits, 4 weeks apart. For the 24 hours prior to each test visit, participants are asked to follow a low polyphenol diet. They are requested not to consume any food or drinks except water 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 testing visits, cognitive and mood battery tests (to include measures of memory, executive functions, and stress, will be taken at baseline, at 2 hours following the consumption of the supplement as part of a meal, and again at 4 weeks following daily consumption of the supplement added to their usual diet. Blood glucose finger pricks will be recorded at each time point along with FMD (a measure of vascular reactivity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50+ years old
- •Fruit & veg intake less than or equal to 4 servings per day
- •Adequate English language and visual & auditory acuity to perform the cognitive tasks
- •Normal BMI for age
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
- •Conditions altering absorption of nutrients (e.g. celiac disease)
- •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
30 participants to receive daily 6g servings of a calorie-matched powder, artificially coloured and flavoured to resemble berry powder
干预措施: Placebo (Dietary Supplement)
Pure haskap berry powder
30 participants to receive daily 6g servings of a pure, freeze-dried haskap berry powder
干预措施: Pure haskap berry powder (Dietary Supplement)
Vitamin- and mineral-enhanced haskap berry powder
30 participants to receive daily 6g servings of a vitamin- and mineral-enhanced haskap berry powder (fortified with potassium iodide, zinc bisglycinate, vitamin B5, and vitamin B12
干预措施: Vitamin-and mineral-enhanced haskap berry powder (Dietary Supplement)
结局指标
主要结局
Delayed recall (Rey Auditory Verbal Learning Task)
时间窗: 4 weeks
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.
次要结局
- Rate of learning (Rey Auditory Verbal Learning Task)(4 weeks)
- Word recognition (Rey Auditory Verbal Learning Task)(4 weeks)
- Modified Attention Network Task (MANT)(4 weeks)
- Task Switching Task(4 weeks)
- Corsi Block Tapping Task(4 weeks)
- Flow mediated dilation (FMD)(4 weeks)
- Blood glucose(4 weeks)
- Blood pressure(4 weeks)
- Positive and Negative Affect Schedule (PANAS-X) performance(4 weeks)
- Stress (Perceived Stress Scale)(4 weeks)
- Rate of learning (Rey Auditory Verbal Learning Task)(Baseline)
- Rate of learning (Rey Auditory Verbal Learning Task)(2 hours)
- Word recognition (Rey Auditory Verbal Learning Task)(Baseline)
- Word recognition (Rey Auditory Verbal Learning Task)(2 hours)
- Modified Attention Network Task (MANT)(Baseline)
- Modified Attention Network Task (MANT)(2 hours)
- Task Switching Task(Baseline)
- Flow mediated dilation (FMD)(2 hours)
- Task Switching Task(2 hours)
- Corsi Block Tapping Task(Baseline)
- Corsi Block Tapping Task(2 hours)
- Flow mediated dilation (FMD)(Baseline)
- Blood glucose(Baseline)
- Blood glucose(2 hours)
- Blood pressure(Baseline)
- Blood pressure(2 hours)
- Positive and Negative Affect Schedule (PANAS-X) performance(Baseline)
- Positive and Negative Affect Schedule (PANAS-X) performance(2 hours)
- Stress (Perceived Stress Scale)(Baseline)
研究者
Prof Claire Williams
Professor
University of Reading