Recruiting
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.
ClinicalTrials.gov IDNCT07477470
PhaseNA
Enrollment120
SponsorMyota GmbH
Age18 Years
SexALL
Conditions studied
Stress
About this study
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.
Interventions
- Dietary Supplement: Prebiotic fibre blend — A blend of prebiotic fibres in a powdered supplement form.
- Dietary Supplement: Maltodextrin (Placebo) — Maltodextrin powder
Primary outcomes
- Perceived Stress (Baseline and 12 weeks)
Eligibility information
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 locations
- BALANCE Study Site, London, EC2A 4BQ United Kingdom
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.