Status:
RECRUITING
CALM Study: Can A Prebiotic Fibre bLend Improve Stress, Mood, and Anxiety?
Lead Sponsor:
Myota GmbH
Collaborating Sponsors:
University of Reading
Conditions:
Stress
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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.
Detailed Description
There is growing interest in how the gut microbiota interacts with the brain to influence psychological outcomes, particularly stress. Even in otherwise healthy individuals, persistent psychological s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT07201909
Start Date
October 2 2025
End Date
December 30 2026
Last Update
December 4 2025
Active Locations (1)
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1
CALM Study Site
London, United Kingdom, EC2A 4BQ