Status:
WITHDRAWN
Dietary Fibers Effect on the Gut Microbiota Composition
Lead Sponsor:
Atlas Biomed
Conditions:
Microbiome
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The randomized double-blinded placebo-controlled multicenter study will be held in parallel groups. During 5 weeks the efficacy of different endpoints as a measure of response to the daily intake of d...
Detailed Description
A randomized double-blinded study will include 270 volunteers without clinical manifestations of chronic diseases. Participants will be randomized into one of five arms daily consuming one of the foll...
Eligibility Criteria
Inclusion
- Subject doesn't have any active complaints
- Subject doesn't have any active or acute diseases at the time of enrollment
- Subject signed informed consent
Exclusion
- High or very high cardiovascular risk
- Levels of total cholesterol and/or low-density lipoproteins requiring immediate assignment of drug treatment (according to ESC Guidelines for the management of dyslipidaemias, 2019)
- Diabetes mellitus of any type
- HbA1с of 5,7% or higher
- Obesity requiring medical therapy or surgery (according to European Guidelines for Adult Obesity Management, 2019)
- Gastrointestinal diseases in history including ulcerative colitis, Crohn's disease, celiac disease, gallbladder disease (calculous cholecystitis, cholangitis, etc.) not related to functional disorders; liver or pancreas diseases
- Irritable bowel syndrome, abdominal pain of any location and etiology
- Pain syndrome of any localization
- Flatulence
- Oncology diseases
- Mental disorders
- Rheumatoid arthritis or other autoimmune diseases
- Acute infectious diseases or exacerbation of any diseases
- Recent (\<3 months) administration of proton pump inhibitors, antimicrobial therapy or surgical intervention
- Recent (\<3 weeks) use of probiotics, antacids, nonsteroidal anti-inflammatory drugs, laxatives
- Pregnancy, planning to be pregnant or breast feeding at any point during the study or study enrollment
- Current alcohol/drug abuse (more than 3 points for women and 4 for men according to AUDIT-C questionnaire and/or more than 7 points on the AUDIT questionnaire) or addiction therapy within 12 months prior to screening
- Allergies to any prebiotic or placebo ingredients
- Planned relocation from the home region during the study
Key Trial Info
Start Date :
November 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04114513
Start Date
November 25 2019
End Date
September 30 2020
Last Update
March 12 2021
Active Locations (1)
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1
Atlas Medical Center
Moscow, Russia