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CALM Study: Can A Prebiotic Fibre bLend Improve Stress, Mood, and Anxiety?
RECRUITINGN/ASponsored by Myota GmbH
Actively Recruiting
PhaseN/A
SponsorMyota GmbH
Started2025-10-02
Est. completion2026-09-30
Eligibility
Age18 Years – 50 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07201909
Summary
This clinical trial will investigate whether a powdered prebiotic fibre blend can improve perceived stress levels in healthy adults with mild-moderate 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 range required for mild-moderate stress levels (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 * Diagnosis of Type 1 or 2 diabetes or cardiovascular disease or psychiatric or neurological conditions (e.g. schizophrenia, dementia) including eating disorders * Current or previous diagnosis of depression in past 6 months * 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) * Currently consuming daily prebiotic or probiotic supplements * Prior use (\< 6 months) of any blood glucose or cholesterol lowering medication * Any significant GI condition affecting GI absorption including (but not limited to) inflammatory bowel disease, weight loss surgery, irritable bowel disease. * End stage renal disease * Active cancer, or treatment for any cancer, in last 3 years * Consuming more than 20g of fibre a day as assessed by the 18-item FiberScreen
Conditions3
AnxietyDepressionStress
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Actively Recruiting
PhaseN/A
SponsorMyota GmbH
Started2025-10-02
Est. completion2026-09-30
Eligibility
Age18 Years – 50 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07201909