Ireland
--:--IST
Recruiting Not applicable

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

NCT07477470 · tracked via the Priya Life Science UK tracker
Sponsor
Myota GmbH
Phase
Not applicable
Started
2026-06-01
Last updated
2026-06-03

Condition(s) studied

Stress

Investigational drug(s) / intervention(s)

Prebiotic fibre blendMaltodextrin (Placebo)

Prebiotic fibre blend: A blend of prebiotic fibres in a powdered supplement form.

Maltodextrin (Placebo): Maltodextrin powder

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Perceived Stress — 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).

Trial sites (1)

FacilityCityRegionStatus
BALANCE Study Site London United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07477470 on ClinicalTrials.gov ↗ ← All trials in the UK