NCT07477470

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Jan 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 12, 2026

Last Update Submit

March 17, 2026

Conditions

Stress

Keywords

gut-brain axisperceived stressprebiotic fibrecognitive functionanxietymooddepressioninflammation

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress

    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 Outcomes (11)

  • Perceived Stress

    Baseline and 8 weeks

  • Depression

    Baseline, 8 weeks and 12 weeks

  • Mood

    Baseline, 8 weeks and 12 weeks

  • Anxiety

    Baseline, Week 8, and Week 12

  • Serum hs-CRP

    Baseline and Week 12

  • +6 more secondary outcomes

Other Outcomes (16)

  • Exploratory: Sleep quality

    Baseline and Week 12

  • Exploratory: Quality of Life Index

    Baseline And Week 12

  • Exploratory: Serum LDL Cholesterol

    Baseline and Week 12

  • +13 more other outcomes

Study Arms (3)

Prebiotic fibre blend (6g)

EXPERIMENTAL

Prebiotic fibre blend, consisting of 6g of a powdered supplement, to be taken daily alongside usual

Dietary Supplement: Prebiotic fibre blend

Prebiotic fibre blend (10g)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo will be 10g of maltodextrin powder, to be taken daily alongside usual diet for 12 weeks.

Dietary Supplement: Maltodextrin (Placebo)

Interventions

Prebiotic fibre blendDIETARY_SUPPLEMENT

A blend of prebiotic fibres in a powdered supplement form.

Prebiotic fibre blend (10g)Prebiotic fibre blend (6g)
Maltodextrin (Placebo)DIETARY_SUPPLEMENT

Maltodextrin powder

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Current smoker
  • Having food allergies and/or intolerances
  • Current diagnosis of Type 1 or 2 diabetes, cardiovascular 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BALANCE Study Site

London, EC2A 4BQ, United Kingdom

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionInflammation

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Thomas Gurry, PhD

CONTACT

797908227thomas@myotahealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Study sponsor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three-arm, double-blind, placebo-controlled randomised trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Participant data will not be shared.

Locations

GB(1)