Image

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

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

Recruiting
18-50 years
All
Phase N/A

Powered by AI

Overview

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

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 stress is associated with measurable physiological changes-including elevated cortisol levels, heightened hypothalamic-pituitary-adrenal (HPA) axis reactivity, and systemic low-grade inflammation. These biological signatures are increasingly understood to be shaped, in part, by the composition and activity of the gut microbiota.

In this study, we're investigating how a powdered prebiotic fibre supplement can improve stress levels. You may have heard people refer to this as the 'gut-brain axis'. We'll also be looking at the link between the prebiotic fibre supplement intake and changes in other areas of health, like depression, mood, anxiety, cognition, inflammation, and the gut microbiome.

Eligibility

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-moderate 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

Study details
    Stress

NCT07201909

Myota GmbH

1 February 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.