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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Stress

In brief

This clinical trial will investigate whether a powdered prebiotic fibre blend can improve perceived stress levels in healthy adults with mild-severe stress levels.

Key facts

Study ID

NCT07201909

Run by

Myota GmbH

People needed

156

Starts

2025-10-02

Expected to finish

2026-12-30

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CALM Study Site — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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