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New treatment option for Stress
Official title BALANCE Study: Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE
ClinicalTrials.gov ID: NCT07477470
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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
You likely can't join if
- 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)...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.