BiomeBakery: A Randomised Controlled Parallel Trial to Investigate the Cognitive, Affective, Inflammatory and Metabolic Effects of Chronic Prebiotic-fortified Functional Bakery Product Intervention in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment score
研究概览
简要总结
This study aims to investigate the chronic effects of prebiotic fibre-fortified functional bakery product on cognitive, affective, inflammatory, metabolic, and anthropometric outcomes in healthy adults aged 60-75 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 an 12 week prebiotic fibre-fortified functional bakery product on cognitive, affective, inflammatory, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints.
Seventy four participants will be randomised (1:1 ratio, matched by age, sex, and fibre intake) to Intervention or Placebo groups where they will be consuming a prebiotic fibre-fortified functional bakery product (containing 10g prebiotic fibre/day) or a regular bakery product (containing 0g prebiotic fibre/day), 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, immediate and delayed verbal memory, executive functions; affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; inflammatory measure of high sensitivity C-reactive protein (hs-CRP); metabolic measures of lipid profiles (total-C, LDL-C, HDL-C, triglycerides), Hemoglobin A1c (HbA1c) and systolic and diastolic blood pressure; and anthropometric measures of height, weight, hip and waist circumference.
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)
- •Having mild to moderate subjective cognitive complaints
- •Consuming bread (5 or more times a week)
排除标准
- •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
- •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 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 fibre-fortified bread roll
Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).
干预措施: Prebiotic fibre fortified bread roll (Dietary Supplement)
Placebo: Regular bread roll
Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).
干预措施: Regular bread roll (Dietary Supplement)
结局指标
主要结局
Montreal Cognitive Assessment score
时间窗: From baseline (pre intervention) to week 12 (post intervention)
Composite measure of global cognitive function - the total possible score is 30 points; a score of 26 or above is considered normal.
hs-CRP levels
时间窗: From baseline (pre intervention) to week 12 (post intervention)
High- sensitivity C-Reactive protein (hs-CRP) levels in plasma samples
次要结局
- 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))
- Word Recognition from the Rey Auditory Verbal Learning Task(From baseline (pre intervention) to week 12 (post intervention))
- EPIC Norfolk Food Frequency Questionnaire (FFQ)(From baseline (pre intervention) to week 12 (post intervention))
- Working Memory Questionnaire Score(From baseline (pre intervention) to week 12 (post intervention))
- Gastrointestinal Symptom Rating Scale Scores(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))
- Positive and Negative Affect Schedule (PANAS)(From baseline (pre intervention) to week 12 (post intervention))
- Lipid profiles(From baseline (pre intervention) to week 12 (post intervention))
- Blood Pressure(From baseline (pre intervention) to week 12 (post intervention))
- Hemoglobin A1c (HbA1c)(From baseline (pre intervention) to week 12 (post intervention))
- Anthropometric outcomes(From baseline (pre intervention) to week 12 (post intervention))
研究者
Piril Hepsomali
Principle Investigator
University of Reading