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
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