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
This trial will test whether a daily powdered prebiotic fibre supplement can lower perceived stress and improve mood and anxiety in healthy adults aged 18–50 who report mild to severe stress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Myota GmbH Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT07201909 on ClinicalTrials.gov |
What this trial studies
Adults who meet the stress-range criteria will be given either a powdered prebiotic fibre blend or a maltodextrin comparator and followed over the intervention period to track changes. Outcomes will include self-reported perceived stress (DASS-42 stress subscale), mood and anxiety measures, cognitive tests, and biological markers such as inflammatory markers, cortisol, and gut microbiome composition. The trial excludes people with major medical or psychiatric diagnoses, current smokers, pregnant or menopausal participants, and those taking certain medications to reduce confounding. Data will be used to link any changes in symptoms with shifts in microbiome composition and physiological stress markers.
Who should consider this trial
Good fit: Healthy adults aged 18–50 who can consent, are non-smokers, not pregnant or menopausal, not taking excluded medications, and who score in the mild to severe range for perceived stress on the DASS-42 are ideal candidates.
Not a fit: People with diagnosed psychiatric or neurological disorders, recent depression, diabetes or cardiovascular disease, current smokers, those on antidepressants, hormonal birth control, or continuous antibiotics, or those who are pregnant or menopausal are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide a low-risk, non-drug option to reduce perceived stress and improve related mood and anxiety symptoms.
How similar studies have performed: Previous small human and animal studies suggest prebiotic fibers can modestly influence stress-related measures and microbiome composition, but results are mixed and larger confirmatory trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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-severe 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
Where this trial is running
London
- CALM Study Site — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Caitlin Hall, PhD, RD
- Email: caitlin@myotahealth.com
- Phone: 07830709854
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.