NCT07477470 BALANCE Study: Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE
| NCT ID | NCT07477470 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Myota GmbH |
| Condition | Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-06-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07477470 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07477470 currently recruiting?
Yes, NCT07477470 is actively recruiting participants. Contact the research team at thomas@myotahealth.com for enrollment information.
Where is the NCT07477470 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07477470 clinical trial?
NCT07477470 is sponsored by Myota GmbH. The trial plans to enroll 120 participants.