Clinical Trials in the UK / NCT07477470
Recruiting
Not applicable
BALANCE Study: Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE
NCT07477470 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Stress
Investigational drug(s) / intervention(s)
Prebiotic fibre blendMaltodextrin (Placebo)
Prebiotic fibre blend: A blend of prebiotic fibres in a powdered supplement form.
Maltodextrin (Placebo): Maltodextrin powder
Study summary
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.
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 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
Primary outcome measure(s)
- Perceived Stress — Baseline and 12 weeks
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).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| BALANCE Study Site | London | United Kingdom | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07477470 on ClinicalTrials.gov ↗ ← All trials in the UK