The Impact of Chronic Consumption of ETAS® for 12 Weeks on Cognitive, Affective, and Inflammatory Outcomes: A Randomised Parallel Group Placebo-controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment (MoCA) score
研究概览
简要总结
This pilot study aims to investigate the chronic effects of ETAS® on cognitive, affective and inflammatory outcomes in healthy adults aged 60-80 years with mild to moderate subjective cognitive complaints.
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 ETAS® consumption on affective, inflammatory, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. Thirty participants will be randomised to Intervention 1, Intervention 2, or Placebo groups where they will be consuming capsules containing 300mg ETAS®, 1500mg ETAS®, or placebo, respectively, 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, executive function, and cognitive failures; affective measures of depression and anxiety symptomatology; quality of life, and sleep; gastrointestinal symptomatology; inflammatory measures of IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, CRP; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. In addition, tau from plasma will be recorded at all timepoints.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aging between 60-80 years old
- •Having normal vision and hearing
- •Having a body mass index between 18.5 and 30
- •Having mild to moderate subjective cognitive complaints
排除标准
- •Having food allergies or intolerances
- •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
- •Being anaemic
- •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 inflammatory bowel disease; coeliac disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years
研究组 & 干预措施
Active 1: ETAS® (300mg)
Subjects will consume 300mg ETAS®/day (capsule).
干预措施: Active 1 ETAS® (Dietary Supplement)
Active 1: ETAS® (1500mg)
Subjects will consume 1500mg ETAS®/day (capsule).
干预措施: Active 2 ETAS® (Dietary Supplement)
Placebo: Matched placebo
Subjects will consume a matched placebo capsule.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA) score
时间窗: From baseline (pre intervention) to week 12 (post intervention)
Composite measure of global cognitive function
Inflammatory biomarker levels
时间窗: From baseline (pre intervention) to week 12 (post intervention)
IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, CRP levels from plasma
次要结局
- Geriatric Depression Scale scores(From baseline (pre intervention) to week 12 (post intervention))
- WHOQOL-BREF score(From baseline (pre intervention) to week 12 (post intervention))
- EPIC Norfolk Food Frequency Questionnaire (FFQ)(From baseline (pre intervention) to week 12 (post intervention))
- Behaviour Rating Inventory of Executive Function Score(From baseline (pre intervention) to week 12 (post intervention))
- Cognitive Failures Questionnaire Score(From baseline (pre intervention) to week 12 (post intervention))
- Geriatric Anxiety Inventory scores(From baseline (pre intervention) to week 12 (post intervention))
- Pittsburgh Sleep Quality Index Scores(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))
- Body Mass Index(From baseline (pre intervention) to week 12 (post intervention))
研究者
Piril Hepsomali
Principle Investigator
University of Reading