PRECOG Pilot Project

NCT ID: NCT06911957

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Cognition Affect (Mental Function) Gut Microbiome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active: prebiotic blend (powder)

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

Group Type EXPERIMENTAL

Prebiotic blend

Intervention Type DIETARY_SUPPLEMENT

10g of prebiotic fibre blend powder

Active: matched placebo (powder)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

10g of matched placebo powder

Interventions

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Prebiotic blend

10g of prebiotic fibre blend powder

Intervention Type DIETARY_SUPPLEMENT

Placebo

10g of matched placebo powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biotechnology and Biological Sciences Research Council

OTHER

Sponsor Role collaborator

Myota Limited

UNKNOWN

Sponsor Role collaborator

i-NutriLife Hub

UNKNOWN

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Piril Hepsomali

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UREC 25/03

Identifier Type: -

Identifier Source: org_study_id

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