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RECRUITINGINTERVENTIONAL

CALM Study: Can A Prebiotic Fibre bLend Improve Stress, Mood, and Anxiety?

Can A Prebiotic Fibre bLend Improve Stress, Mood, and Anxiety? Assessing the Impact of a Daily Prebiotic Fibre Blend on Affect, Inflammation, and the Gut Microbiome: a 12-week Double-blind Placebo-controlled RCT

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This clinical trial will investigate whether a powdered prebiotic fibre blend can improve perceived stress levels in healthy adults with mild-severe stress levels.

Who May Be Eligible (Plain English)

Who May Qualify: - Aged 18-50 years of age - Capacity to give willing to sign a consent form to participate in the study - Able to comply with study requirements and visits - Meet the range required for mild-severe stress levels (as assessed by DASS-42 stress subscale) - Normal or corrected to normal vision and/or hearing Who Should NOT Join This Trial: - Current smoker - Having food allergies and/or intolerances - Diagnosis of Type 1 or 2 diabetes or cardiovascular disease or psychiatric or neurological conditions (e.g. schizophrenia, dementia) including eating disorders - Current or previous diagnosis of depression in past 6 months - 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) - Currently consuming daily prebiotic or probiotic supplements - Prior use (\< 6 months) of any blood glucose or cholesterol lowering medication - Any significant GI condition affecting GI absorption including (but not limited to) inflammatory bowel disease, weight loss surgery, irritable bowel disease. - End stage renal disease - Active cancer, or treatment for any cancer, in last 3 years - Consuming more than 20g of fibre a day as assessed by the 18-item FiberScreen Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 range required for mild-severe stress levels (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 * Diagnosis of Type 1 or 2 diabetes or cardiovascular disease or psychiatric or neurological conditions (e.g. schizophrenia, dementia) including eating disorders * Current or previous diagnosis of depression in past 6 months * 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) * Currently consuming daily prebiotic or probiotic supplements * Prior use (\< 6 months) of any blood glucose or cholesterol lowering medication * Any significant GI condition affecting GI absorption including (but not limited to) inflammatory bowel disease, weight loss surgery, irritable bowel disease. * End stage renal disease * Active cancer, or treatment for any cancer, in last 3 years * Consuming more than 20g of fibre a day as assessed by the 18-item FiberScreen

Treatments Being Tested

DIETARY_SUPPLEMENT

Prebiotic fibre blend

A blend of prebiotic fibres in a powdered supplement form.

DIETARY_SUPPLEMENT

Maltodextrin powder

Maltodextrin powder

Locations (1)

CALM Study Site
London, United Kingdom