BALANCE Study: Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE
Recruiting · NCT07477470 · Interventional (participants receive a specific treatment) · Lead sponsor: Myota GmbH
View the official record on ClinicalTrials.gov →Interventions studied
Maltodextrin (Placebo)Prebiotic fibre blend
What this trial is about
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.
Who can take part
Age range
18 Years to 50 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- BALANCE Study Site - London, United Kingdom
- BALANCE Study Site - London, United Kingdom