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NCT Number: NCT07477470

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

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.

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Key information

Conditions

Stress Anxiety Disorders Behavior Behavioral Symptoms Depression Inflammation Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BALANCE Study Site

London, EC2A 4BQ, United Kingdom

Location status: Recruiting

Location contact

Caitlin Hall, PhD

CONTACT

[email protected]

7830709854 ext. +44

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Prebiotic fibre blend

Dietary Supplement

A blend of prebiotic fibres in a powdered supplement form.

Maltodextrin (Placebo)

Dietary Supplement

Maltodextrin powder

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  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).

  13. 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).

  14. 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).

  15. 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).

  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).

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Gurry, PhD

CONTACT

[email protected]

797908227 ext. +41

Sponsors and collaborators

Lead sponsor

Myota GmbH

Industry

Collaborators

  • University of Reading

Registry information

Official study title

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

Acronym: BALANCE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2026
Registry last updated
Jun 3, 2026

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.

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