Clinical trial NCT04114513: Dietary Fibers Effect on the Gut Microbiota Composition
Official title: A Randomized, Placebo-controlled, Double-blinded, Parallel-group, 5-week Study of the Dietary Fibers Intake (Inulin, Pectin, Beta-glucan, Galactooligosaccharides) Influence on the Gut Microbiota Composition and Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Microbiome
Metabolic Syndrome
Cardiovascular Risk Factor
Inflammation
Dyslipidemias
Keywords: Dietary fiber
Gut Microbiota
Cardiovascular risk factors
Lipid metabolism
Lead sponsor: Atlas Biomed
Sponsor class: INDUSTRY
First posted: 2019-10-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 dietary fibers (8 g of either inulin, pectin, beta-glucan or galactooligosaccharides) will be evaluated. Gut microbiota composition, lipids levels, inflammation markers, microbiome metabolites, changes in quality of life and stool parameters will be assessed in order to predict individual response in participants without serious chronic diseases

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 following: placebo (maltodextrin, 8 g), inulin (8 g), pectin (8 g), beta-glucan (8 g) or oligosaccharides (8 g).

The study will include a 5-day screening period and a 5-weeks intervention period.

During screening stage, a volunteer will complete a questionnaire, and the following measurements will be performed: blood levels of glycated hemoglobin, creatinine, lipids, C-reactive protein, anthropometric measurements, as well as cardiovascular risk will be assessed.

Before and after the intervention blood and stool samples will be collected to conduct the following analyses: an extended lipid spectrum analysis, high-sensitivity C-reactive protein, 16S rRNA gut microbiome sequencing, laboratory stool testing, stool fecal short-chain fatty acids analysis. Anthropometric measures, physical examination will be performed for each volunteer. The following questionnaires will be completed: dietary recall questionnaire, SF-36, the Rome Criteria for the Functional gastrointestinal disorders (functional constipation). The assessed scales will include Bristol stool scale, Hospital Anxiety and Depression Scale (HADS), Hamilton Rating Scale for Depression (HRSD).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Blood lipids levels
timeFrame: Change from Baseline Blood lipids levels at 5th week
measure: Change in Gut microbiota composition
timeFrame: Change from Baseline at 5th week
Secondary outcomes:
measure: Change in Fecal short-chain fatty acids
timeFrame: Change from Baseline at 5th week
measure: Change in High sensitive C-reactive protein
timeFrame: Change from Baseline at 5th week
measure: Change in Stool consistency
timeFrame: Change from Baseline at 5th week
measure: Change in Stool frequency
timeFrame: Change from Baseline at 5th week
measure: Change in Body Composition
timeFrame: Baseline and 5th week
measure: Change in Quality of Life: SF-36 questionnaire
timeFrame: Change from Baseline at 5th week
measure: Change in Psychological distress
timeFrame: Change from Baseline at 5th week
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Atlas Medical Center
Study officials:
References: