RecruitingNot ApplicableNCT07477470

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

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

Sponsor

Myota GmbH

Enrollment

120 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Stress

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

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria5

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 Criteria17

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