BALANCE Study: Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE (BALANCE)

June 1, 2026 updated by: Myota GmbH

Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE: a Double-blind Placebo Controlled Randomised Controlled Trial

This clinical trial will investigate whether a powdered prebiotic fibre blend, at two doses, can improve perceived stress levels in healthy adults with mild-severe stress levels.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There is growing interest in how the gut microbiota interacts with the brain to influence psychological outcomes, particularly stress. Even in otherwise healthy individuals, persistent psychological stress is associated with measurable physiological changes-including elevated cortisol levels, heightened hypothalamic-pituitary-adrenal (HPA) axis reactivity, and systemic low-grade inflammation. These biological signatures are increasingly understood to be shaped, in part, by the composition and activity of the gut microbiota.

This study will investigate how a powdered prebiotic fibre supplement can affect stress levels. Secondary endpoints include the effects that the prebiotic fibre supplement will have on other areas of health, like depression, mood, anxiety, cognition, inflammation, and the gut microbiome.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18-50 years of age
  • Capacity to give informed consent to participate in the study
  • Able to comply with study requirements and visits
  • Meet the criteria for mild-severe stress levels (scores between 15-33) as assessed by DASS-42 Stress Subscale
  • Normal or corrected to normal vision and/or hearing

Exclusion Criteria:

  • Current smoker
  • Having food allergies and/or intolerances
  • Current diagnosis of Type 1 or 2 diabetes, cardiometabolic disease, or psychiatric or neurological conditions (e.g. schizophrenia, dementia) including eating disorders
  • Current or previous diagnosis of depression in past 6 months
  • Currently receiving medications that lower cholesterol, blood pressure, blood glucose levels, or improve insulin sensitivity
  • Receiving antidepressant or anti-anxiety medications or treatments
  • Receiving hormonal birth control
  • Perimenopause or menopause
  • Pregnancy, lactation, or an intent to become pregnant during the course of the study
  • Continuous antibiotic use for > 3 days within 1 month prior to enrolment
  • Continuous use of weight-loss drug for > 1 month before screening
  • Major change in dietary intake in past month (e.g. excluding whole food groups)
  • Consuming a restricted diet, including a vegan, vegetarian, and ketogenic diet
  • Currently consuming daily prebiotic or probiotic supplements
  • Any significant GI condition affecting absorption including (but not limited to) inflammatory bowel disease, weight loss surgery, irritable bowel syndrome.
  • Active cancer, or treatment for any cancer, in last 3 years
  • Consuming more than 20g of fibre a day as assessed by the FiberScreen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo will be 10g of maltodextrin powder, to be taken daily alongside usual diet for 12 weeks.
Dietary supplement: Maltodextrin (Placebo)
Maltodextrin powder
Experimental: Prebiotic fibre blend (6g)
Prebiotic fibre blend, consisting of 6g of a powdered supplement, to be taken daily alongside usual
Dietary supplement: Prebiotic fibre blend
A blend of prebiotic fibres in a powdered supplement form.
Experimental: Prebiotic fibre blend (10g)
Prebiotic fibre blend, consisting of 10g of a powdered supplement, to be taken daily alongside usual diet for 12 weeks.
Dietary supplement: Prebiotic fibre blend
A blend of prebiotic fibres in a powdered supplement form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress
Time Frame: Baseline and 12 weeks
The primary objective is to determine the effect of 12-week long daily administration of Prebiotic fibre blend as compared to Placebo on stress scores (Perceived Stress Scale) on a scale between 0 - 40 (where higher scores indicate higher stress).
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress
Time Frame: Baseline and 8 weeks
To determine the effect of 12-week long daily administration of Prebiotic fibre blend as compared to Placebo on stress scores (Perceived Stress Scale) on a scale between 0 - 40 (where higher scores indicate higher stress).
Baseline and 8 weeks
Mood
Time Frame: Baseline, 8 weeks and 12 weeks
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on mood scores (PANAS-X), on a scale between 10 - 50 (where higher scores on the Positive Affect scale indicate higher levels of positive engagement with your environment; while higher scores on the Negative Affect scale indicate higher levels of negative engagement).
Baseline, 8 weeks and 12 weeks
Serum hs-CRP
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on serum high sensitivity C-Reactive Protein (hs-CRP).
Baseline and Week 12
Cognition: Affective 2-Back Task
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on emotional interference in working memory under emotional load, as assessed by the Affective 2-Back Task, where better scores are achieved by lower reaction times and higher accuracy score.
Baseline and Week 12
Depression
Time Frame: Baseline, 8 weeks and 12 weeks
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on depression scores (PHQ-8), on a scale between 0 - 24 (where higher scores mean higher depression).
Baseline, 8 weeks and 12 weeks
Anxiety
Time Frame: Baseline, Week 8, and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on anxiety scores (GAD-7), on a scale between 0 - 21 (where higher scores mean higher anxiety levels).
Baseline, Week 8, and Week 12
Cognition: Auditory Verbal Learning Task (AVLT)
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on immediate and delayed word recognition, as assessed by the AVLT where better scores are achieved by higher number or recalled words and lower error rate.
Baseline and Week 12
Cognition: Emotional Go/No-Go
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on emotion-related inhibitory control and response suppression, as assessed by the Emotional Go-No-Go, where better scores are achieved by higher correct response rates and lower commission errors.
Baseline and Week 12
Cognition: Attentional Network Task (ANT)
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on efficiency of alerting, orienting, and executive attention networks, as assessed by the Attentional Network Task, where better scores are achieved by lower reaction times and higher accuracy.
Baseline and Week 12
Cognition: Number Letter Task
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on cognitive flexibility and task-switching ability, as assessed by the Number Letter Task where better scores are achieved by a higher accuracy of recalled sequences.
Baseline and Week 12
Gastrointestinal symptoms
Time Frame: Baseline, Week 8 and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on gastrointestinal symptoms (GSRS), on a scale of 15 - 105 where higher scores indicate more severe gastrointestinal discomfort.
Baseline, Week 8 and Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory: Sleep quality
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on sleep quality (PSQI), on a scale of 0 - 21 where higher scores indicate worse sleep.
Baseline and Week 12
Exploratory: Quality of Life Index
Time Frame: Baseline And Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on quality of life index (WHOQOL), on a scale of 0 -100 where higher scores indicate higher quality of life.
Baseline And Week 12
Exploratory: Serum LDL Cholesterol
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on serum LDL cholesterol.
Baseline and Week 12
Exploratory: Serum HDL Cholesterol
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on serum HDL cholesterol.
Baseline and Week 12
Exploratory: Serum Triglycerides
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on serum triglycerides.
Baseline and Week 12
Exploratory: Total cholesterol
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on serum total cholesterol.
Baseline and Week 12
Exploratory: Waist to hip ratio
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on waist to hip ratio.
Baseline and Week 12
Exploratory: Waist circumference
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on waist circumference (cm).
Baseline and Week 12
Exploratory: Gut microbiome composition
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on gut microbiome diversity scores (alpha and beta measures) and composition (differential abundance testing).
Baseline and Week 12
Exploratory: Systolic blood pressure
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on systolic blood pressure (mmHg).
Baseline and Week 12
Exploratory: Diastolic blood pressure
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on diastolic blood pressure (mmHg).
Baseline and Week 12
Exploratory: BMI
Time Frame: Baseline and Week 12
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on body mass index (BMI) (kg/m2).
Baseline and Week 12
Exploratory: Perceived Stress (follow-up)
Time Frame: Week 12 and Week 16
To determine the follow-up (week 16) effects of Prebiotic fibre blend, as compared to Placebo, on stress scores (PSS) on a scale between 0 - 40 (where higher scores indicate higher stress).
Week 12 and Week 16
Exploratory: Depression (follow-up)
Time Frame: Week 12, and Week 16
To determine the follow-up (week 16) effects of Prebiotic fibre blend, as compared to Placebo, on depression scores (PHQ-8) on a scale between 0 - 24 (where higher scores indicate higher stress).
Week 12, and Week 16
Exploratory: Mood (follow-up)
Time Frame: Week 12 and Week 16
To determine the follow-up (week 16) effects of Prebiotic fibre blend, as compared to Placebo, on mood scores (PANAS-X) on a scale between 10 - 50 (where higher scores on the Positive Affect scale indicate higher levels of positive engagement with your environment; while higher scores on the Negative Affect scale indicate higher levels of negative engagement).
Week 12 and Week 16
Exploratory: Anxiety (follow-up)
Time Frame: Week 12 and Week 16
To determine the follow-up (week 16) effects of Prebiotic fibre blend, as compared to Placebo, on anxiety scores (GAD-7) on a scale between 0 - 21 (where higher scores mean higher anxiety levels).
Week 12 and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myota GmbH

Collaborators

University of Reading

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BALANCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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