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Recruiting NCT07477470

BALANCE Study: Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE

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 (Placebo).
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

Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE: a Double-blind Placebo Controlled Randomised Controlled Trial

Overview

This clinical trial will investigate whether a powdered prebiotic fibre blend, at two doses, 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.

This study will investigate how a powdered prebiotic fibre supplement can affect stress levels. Secondary endpoints include the effects that the prebiotic fibre supplement will have on 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 (Placebo)
    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]
  • Cognition: Auditory Verbal Learning Task (AVLT) [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: Attentional Network Task (ANT) [Time frame: Baseline and Week 12]
  • Cognition: Number Letter Task [Time frame: Baseline and Week 12]
  • Gastrointestinal symptoms [Time frame: Baseline, Week 8 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 criteria for mild-severe stress levels (scores between 15-33) 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
  • Current diagnosis of Type 1 or 2 diabetes, cardiometabolic disease, or psychiatric or neurological conditions (e.g. schizophrenia, dementia) including eating disorders
  • Current or previous diagnosis of depression in past 6 months
  • Currently 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)
  • Consuming a restricted diet, including a vegan, vegetarian, and ketogenic diet
  • Currently consuming daily prebiotic or probiotic supplements
  • Any significant GI condition affecting absorption including (but not limited to) inflammatory bowel disease, weight loss surgery, irritable bowel syndrome.
  • Active cancer, or treatment for any cancer, in last 3 years
  • Consuming more than 20g of fibre a day as assessed by the 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
Triple blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • BALANCE Study Site — London

Identifiers

NCT: NCT07477470 · BALANCE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗