PRECOG Pilot Project

Not Applicable

Not yet recruiting

• Conditions: Cognition; Affect (Mental Function); Gut Microbiome

• Registration Number: NCT06911957
• Lead Sponsor: University of Reading

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 Timeline

• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-27
• Status Verified: 2025-04
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-20
• Study Start: 2025-05-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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
• Smoking
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive Drug Research Computerized Assessment System (COGDRAS) scores	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	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	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 Outcome Measures

Name	Time	Method
Body Mass Index	From baseline (pre intervention) to week 12 (post intervention)	Weight (in kg) and height (in m) will be combined to report BMI in kg/m\^2.
Geriatric Depression Scale scores	From baseline (pre intervention) to week 12 (post intervention)	A validated self-report measure of depression that includes 15-items.
Geriatric Anxiety Inventory scores	From baseline (pre intervention) to week 12 (post intervention)	A validated self-report measure of anxiety that includes 20-items.
Montreal Cognitive Assessment (MoCA) score	From baseline (pre intervention) to week 12 (post intervention)	Composite measure of global cognitive function
Gastrointestinal Symptom Rating Scale Scores	From baseline (pre intervention) to week 12 (post intervention)	A validated self-report measure of gastrointestinal symptoms that includes 15-items (combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation) .
Blood Pressure	From baseline (pre intervention) to week 12 (post intervention)	Systolic and diastolic blood pressure (in mmHg) will be measured.
Positive and Negative Affect Schedule (PANAS)	From baseline (pre intervention) to week 12 (post intervention)	A 20-item questionnaire measuring positive and negative affect.
Hip and waist circumference	From baseline (pre intervention) to week 12 (post intervention)	Hip and waist circumference (in cm) will be measured.

Trial Locations

Locations (1)

University of Reading, School of Psychology and Clinical Languages; 🇬🇧 Reading, Berkshire, United Kingdom