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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Reading
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Cognitive Drug Research Computerized Assessment System (COGDRAS) scores
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aging between 60-75 years old
- •Having normal vision and hearing
- •Having a normal body mass index (BMI<30)
Exclusion Criteria
- •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
Arms & Interventions
Active: prebiotic blend (powder)
Subjects will consume 10g of prebiotic fibre powder in their tea/coffee/water at breakfast.
Intervention: Prebiotic blend (Dietary Supplement)
Active: matched placebo (powder)
Subjects will consume 10g of matched placebo powder in their tea/coffee/water at breakfast.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Cognitive Drug Research Computerized Assessment System (COGDRAS) scores
Time Frame: 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
Time Frame: 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
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
Stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing).
Secondary Outcomes
- 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))
Investigators
Piril Hepsomali
Principle Investigator
University of Reading