|

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

RECRUITINGN/ASponsored by Myota GmbH
Actively Recruiting
PhaseN/A
SponsorMyota GmbH
Started2026-06-01
Est. completion2028-01-01
Eligibility
Age18 Years – 50 Years
Healthy vol.Accepted

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

Age: 18 Years – 50 YearsHealthy volunteers accepted
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

Conditions3

AnxietyDepressionStress

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.