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

RecruitingNAAges 18 Years - 50 YearsAllMyota GmbH
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Prebiotic fibre blend
  • Maltodextrin (Placebo)
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Where

1 site
BALANCE Study Site
London, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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