PRECOG Pilot Project

NCT06911957 | Completed

• 1 other identifier: UREC 25/03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition; Affect (Mental Function); Gut Microbiome

Keywords

prebiotics; cognition; depression; anxiety; gut microbiome diversity; relative abundance

Outcome Measures

Primary Outcomes (3)

• Cognitive Drug Research Computerized Assessment System (COGDRAS) scores

  The COGDRAS battery consists of 8 individual cognitive tests testing memory, attention and reaction times.

  From baseline (pre intervention) to week 12 (post intervention)

• Gut microbiome diversity

  Stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing).

  From baseline (pre intervention) to week 12 (post intervention)

• Gut microbiome composition

  Stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing).

  From baseline (pre intervention) to week 12 (post intervention)

Secondary Outcomes (8)

• 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)

Other Outcomes (3)

• Telephone Interview for Cognitive Status-40

  Baseline (pre intervention)

• FiberScreen Scores

  Baseline (pre intervention)

• EPIC Norfolk Food Frequency Questionnaire (FFQ)

  Baseline (pre intervention)

Study Arms (2)

Active: prebiotic blend (powder)

EXPERIMENTAL

Subjects will consume 10g of prebiotic fibre powder in their tea/coffee/water at breakfast.

Dietary Supplement: Prebiotic blend

Active: matched placebo (powder)

PLACEBO COMPARATOR

Subjects will consume 10g of matched placebo powder in their tea/coffee/water at breakfast.

Dietary Supplement: Placebo

Interventions

Prebiotic blend DIETARY_SUPPLEMENT

10g of prebiotic fibre blend powder

Active: prebiotic blend (powder)

Placebo DIETARY_SUPPLEMENT

10g of matched placebo powder

Active: matched placebo (powder)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aging between 60-75 years old
• Having normal vision and hearing
• Having a normal body mass index (BMI\<30)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• Biotechnology and Biological Sciences Research Council: collaborator
• Myota Limited: collaborator
• i-NutriLife Hub: collaborator

Study Sites (1)

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, RG6 6ES, United Kingdom

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)