RecruitingNot ApplicableNCT07201909

CALM Study: Can A Prebiotic Fibre bLend Improve Stress, Mood, and Anxiety?

Can A Prebiotic Fibre bLend Improve Stress, Mood, and Anxiety? Assessing the Impact of a Daily Prebiotic Fibre Blend on Affect, Inflammation, and the Gut Microbiome: a 12-week Double-blind Placebo-controlled RCT

Sponsor

Myota GmbH

Enrollment

156 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

Stress

Summary

This clinical trial will investigate whether a powdered prebiotic fibre blend 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 range required for mild-severe stress levels (as assessed by DASS-42 stress subscale)
Normal or corrected to normal vision and/or hearing

Exclusion Criteria18

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