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

NCT07201909 | Recruiting

• 1 other identifier: CALM
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress

Keywords

gut-brain axis; perceived stress; prebiotic fibre; cognitive function; anxiety; mood; depression; inflammation

Outcome Measures

Primary Outcomes (1)

• Perceived Stress

  The primary objective is to determine the effect of 12-week long daily administration of Prebiotic fibre blend as compared to Placebo on stress scores (Perceived Stress Scale) on a scale between 0 - 40 (where higher scores indicate higher stress).

  Baseline and 12 weeks

Secondary Outcomes (11)

• Perceived Stress

  Baseline and 8 weeks

• Depression

  Baseline, 8 weeks, and 12 weeks

• Mood

  Baseline, 8 weeks and 12 weeks

• Anxiety

  Baseline, Week 8, and Week 12

• Serum hs-CRP

  Baseline and Week 12

Other Outcomes (13)

• Sleep Quality

  Baseline and Week 12

• Quality of Life Index

  Baseline And Week 12

• Serum LDL Cholesterol

  Baseline and Week 12

Study Arms (2)

Prebiotic fibre blend

EXPERIMENTAL

Prebiotic fibre blend, consisting of 10g of a powdered supplement, to be taken daily alongside usual diet for 12 weeks.

Dietary Supplement: Prebiotic fibre blend

Placebo

PLACEBO COMPARATOR

Placebo will be 10g of maltodextrin powder, to be taken daily alongside usual diet for 12 weeks.

Dietary Supplement: Maltodextrin powder

Interventions

Prebiotic fibre blend DIETARY_SUPPLEMENT

A blend of prebiotic fibres in a powdered supplement form.

Prebiotic fibre blend

Maltodextrin powder DIETARY_SUPPLEMENT

Maltodextrin powder

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Myota GmbH: lead
• University of Reading: collaborator

Study Sites (1)

CALM Study Site

London, EC2A 4BQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Inflammation

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Caitlin Hall, PhD, RD

CONTACT

07830709854; caitlin@myotahealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study Sponsor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-arm, double-blind, placebo-controlled randomised trial

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: October 1, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)