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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

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

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