The Impact of Chronic Consumption of Plant-based Fibres on Cognitive Performance, Gut Microbiome and Mental Health Outcomes in Older Adults: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cognitive Drug Research Computerized Assessment System (COGDRAS) scores
研究概览
简要总结
This pilot study aims to investigate the chronic effects of a prebiotic blend on cognitive, affective and gut microbiome outcomes in healthy adults aged 60-75 years.
详细描述
This pilot study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 12-week-long prebiotic blend consumption on cognitive, affective, gut microbiome, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. Fifty participants will be randomised to Intervention or Placebo groups where they will be consuming 10g of prebiotic fibre blend or 10g of placebo (matched placebo powder) per day for 12-weeks. Outcome measures will be acquired before and after a 12-week chronic supplementation. These will include cognitive measures of overall cognitive functioning, and domain-specific cognitive performance, affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. In addition, stool samples will be collected at all timepoints to assess microbiome diversity and composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aging between 60-75 years old
- •Having normal vision and hearing
- •Having a normal body mass index (BMI<30)
排除标准
- •Having mild to moderate subjective cognitive complaints
- •Having food allergies
- •Following restrictive and/or unbalanced diets
- •Changing dietary intake majorly in past month
- •Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders
- •Being diagnosed with any cardiometabolic diseases (including type II diabetes and cardiovascular disease), or suffering from hypertension or thrombosis related disorders or suffer from thyroid disease
- •Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
- •Currently consuming prebiotic or probiotic supplements
- •Continuous antibiotic use for > 3 days within 1 month prior to enrolment
- •Continuous use of weight-loss drug for > 1 month before screening
- •Having a significant gastrointestinal (GI) condition affecting absorption including (but not limited to) inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years
- •Having a high fibre intake defined as > 20g of fibre/day
- •Wheat and/or gluten intolerance and having coeliac disease
研究组 & 干预措施
Active: prebiotic blend (powder)
Subjects will consume 10g of prebiotic fibre powder in their tea/coffee/water at breakfast.
干预措施: Prebiotic blend (Dietary Supplement)
Active: matched placebo (powder)
Subjects will consume 10g of matched placebo powder in their tea/coffee/water at breakfast.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Cognitive Drug Research Computerized Assessment System (COGDRAS) scores
时间窗: From baseline (pre intervention) to week 12 (post intervention)
The COGDRAS battery consists of 8 individual cognitive tests testing memory, attention and reaction times.
Gut microbiome diversity
时间窗: From baseline (pre intervention) to week 12 (post intervention)
Stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing).
Gut microbiome composition
时间窗: From baseline (pre intervention) to week 12 (post intervention)
Stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing).
次要结局
- Positive and Negative Affect Schedule (PANAS)(From baseline (pre intervention) to week 12 (post intervention))
- Body Mass Index(From baseline (pre intervention) to week 12 (post intervention))
- Geriatric Depression Scale scores(From baseline (pre intervention) to week 12 (post intervention))
- Geriatric Anxiety Inventory scores(From baseline (pre intervention) to week 12 (post intervention))
- Montreal Cognitive Assessment (MoCA) score(From baseline (pre intervention) to week 12 (post intervention))
- Gastrointestinal Symptom Rating Scale Scores(From baseline (pre intervention) to week 12 (post intervention))
- Blood Pressure(From baseline (pre intervention) to week 12 (post intervention))
- Hip and waist circumference(From baseline (pre intervention) to week 12 (post intervention))
研究者
Piril Hepsomali
Principle Investigator
University of Reading