Skip to main content
OpenTrials
Completed

NCT Number: NCT06911957

PRECOG Pilot Project

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognition Affect (Mental Function) Anxiety Disorders Behavior Behavioral Symptoms Depression Gut Microbiome Mental Disorders

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, RG6 6ES, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prebiotic blend

Dietary Supplement

10g of prebiotic fibre blend powder

Placebo

Dietary Supplement

10g of matched placebo powder

Primary outcomes

  1. 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.

  2. 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).

  3. 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

  1. Geriatric Depression Scale scores

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    A validated self-report measure of depression that includes 15-items.

  2. Geriatric Anxiety Inventory scores

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    A validated self-report measure of anxiety that includes 20-items.

  3. Montreal Cognitive Assessment (MoCA) score

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    Composite measure of global cognitive function

  4. Gastrointestinal Symptom Rating Scale Scores

    Time frame: 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) .

  5. Blood Pressure

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    Systolic and diastolic blood pressure (in mmHg) will be measured.

  6. Positive and Negative Affect Schedule (PANAS)

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    A 20-item questionnaire measuring positive and negative affect.

  7. Hip and waist circumference

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    Hip and waist circumference (in cm) will be measured.

  8. Body Mass Index

    Time frame: 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.

Other outcomes

  1. Telephone Interview for Cognitive Status-40

    Time frame: Baseline (pre intervention)

    A questionnaire that assesses cognitive status. It will be used to screen participants. Only individuals who score between 6 and 20 (depicting mild to moderate subjective cognitive complaints) will be included in the study.

  2. FiberScreen Scores

    Time frame: Baseline (pre intervention)

    A questionnaire that assesses fibre intake. It will be used to screen participants. Individuals who adhere to a high fibre diet (>20g fibre/day) will be excluded from the study.

  3. EPIC Norfolk Food Frequency Questionnaire (FFQ)

    Time frame: Baseline (pre intervention)

    The FFQ is a validated tool for gauging the average habitual dietary intake of micro and macronutrients of an individual in the UK. Data will be processed using the FETA software.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Biotechnology and Biological Sciences Research Council
  • Myota Limited
  • i-NutriLife Hub

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.