Menu
Recruiting NCT07201909

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

No phase Interventional Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prebiotic fibre blend, Maltodextrin powder.
Who it may be relevant to
Registry conditions: Stress. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Dietary supplement Prebiotic fibre blend
    A blend of prebiotic fibres in a powdered supplement form.
  • Dietary supplement Maltodextrin powder
    Maltodextrin powder

Primary outcome measures

  • Perceived Stress [Time frame: Baseline and 12 weeks]
Secondary outcome measures (11)
  • Perceived Stress [Time frame: Baseline and 8 weeks]
  • Depression [Time frame: Baseline, 8 weeks, and 12 weeks]
  • Mood [Time frame: Baseline, 8 weeks and 12 weeks]
  • Anxiety [Time frame: Baseline, Week 8, and Week 12]
  • Serum hs-CRP [Time frame: Baseline and Week 12]
  • Gastrointestinal symptoms [Time frame: Baseline, Week 8, and Week 12]
  • Cognition: Emotional Stroop [Time frame: Baseline and Week 12]
  • Cognition: Affective 2-Back Task [Time frame: Baseline and Week 12]
  • Cognition: Emotional Go-No-Go [Time frame: Baseline and Week 12]
  • Cognition: Number-Letter Task [Time frame: Baseline and Week 12]
  • Cognition: Attentional Network Task [Time frame: Baseline and Week 12]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • CALM Study Site — London

Identifiers

NCT: NCT07201909 · CALM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗