The Impact of Chronic Consumption of ETAS® for 12 Weeks on Cognitive, Affective, and Neural Outcomes: A Randomised Parallel Group Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment (MoCA) score
研究概览
简要总结
This study aims to investigate the chronic effects of ETAS® on cognitive, affective and neural outcomes in healthy adults aged 60-80 years with mild to moderate subjective cognitive complaints.
详细描述
This 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. Sixty participants will be randomised to Intervention or Placebo groups where they will be consuming capsules containing 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 language/memory; affective measures of depression and anxiety symptomatology; and sleep; gastrointestinal symptomatology ; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. Brain structure, function, and chemistry at both time points. Furthermore, random selection of participants (n=30, 15 in each group) will receive at home stool sample collection kits and microbiome diversity and compoisiton will be analysed at two time points.
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
- •Following restrictive and/or unbalanced diets (Appendix 6: Are you vegetarian or vegan? Yes / No; Are you currently on a weight-reducing or other special diet? Yes/No If 'Yes', please give details.)
- •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 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
- •History of claustrophobia
- •Fitted with a pacemaker or artificial heart valve
- •Have active implants, such as cochlear, ocular, or penile implant
- •Experience of metal fragments e.g. shrapnel in your eyes or any other part of your body
- •Drug infusion pump installed
- •Have any surgically implanted metal in any part of your body, other than dental fillings and crowns (e.g. joint replacement or bone re-construction)
- •Have had any surgery that might have involved metal implants
- •Current or historical experience of epilepsy
- •Have stimulators for nerves, brain or bone installed
- •Have an intrauterine contraceptive device installed (IUD)
- •Wear transdermal patches containing metal
- •Wear a filling, crown, dental post (entirely within the tooth) associated with root canal treatment, retainer, bridge or braces
- •For scanning, would need to remove coloured contact lenses, nail polish and makeup.
- •Hearing aid wearer
- •Body piercings that you cannot or will not remove for the scanning session
- •Have tattoos or permanent makeup
研究组 & 干预措施
ETAS® (1500mg)
Subjects will consume 1500mg ETAS®/day (capsule).
干预措施: ETAS® (Dietary Supplement)
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
fMRI
时间窗: From baseline (pre intervention) to week 12 (post intervention)
Functional brain activity will be analysed during cognitive tasks.
MRS
时间窗: From baseline (pre intervention) to week 12 (post intervention)
MRS will be used to assess neurochemistry of the medial temporal lobe and medial frontal cortex at rest.
次要结局
- Pittsburgh Sleep Quality Index Scores(From baseline (pre intervention) to week 12 (post intervention))
- Immediate Word Recall from the Rey Auditory Verbal Learning Task(From baseline (pre intervention) to week 12 (post intervention))
- Delayed Word Recall from the Rey Auditory Verbal Learning Task(From baseline (pre intervention) to week 12 (post intervention))
- Gastrointestinal Symptom Rating Scale Scores(From baseline (pre intervention) to week 12 (post intervention))
- Brain structure(From baseline (pre intervention) to week 12 (post intervention))
- Patient Healthcare Questionnaire 8 (PHQ-8)(From baseline (pre intervention) to week 12 (post intervention))
- Generalised anxiety disorder 7 item scale (GAD-7)(From baseline (pre intervention) to week 12 (post intervention))
- EPIC Norfolk Food Frequency Questionnaire (FFQ)(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