Dietary Fibers Effect on the Gut Microbiota Composition

NCT04114513 | Withdrawn DMC

• 1 other identifier: DFI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Microbiome; Metabolic Syndrome; Cardiovascular Risk Factor; Inflammation; Dyslipidemias

Keywords

Dietary fiber; Gut Microbiota; Cardiovascular risk factors; Lipid metabolism

Outcome Measures

Primary Outcomes (2)

• Blood lipids levels

  LDL, HDL, TC, TG, apoB, Lp(a)

  Change from Baseline Blood lipids levels at 5th week

• Change in Gut microbiota composition

  Relative abundance of bacterial taxa according to 16S rRNA sequencing data

  Change from Baseline at 5th week

Secondary Outcomes (7)

• Change in Fecal short-chain fatty acids

  Change from Baseline at 5th week

• Change in High sensitive C-reactive protein

  Change from Baseline at 5th week

• Change in Stool consistency

  Change from Baseline at 5th week

• Change in Stool frequency

  Change from Baseline at 5th week

• Change in Body Composition

  Baseline and 5th week

Study Arms (5)

Maltodextrin

PLACEBO COMPARATOR

Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water.

Dietary Supplement: Maltodextrin

Inulin

EXPERIMENTAL

Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water.

Dietary Supplement: Inulin

Pectin

EXPERIMENTAL

Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water.

Dietary Supplement: Pectin

Beta-glucan

EXPERIMENTAL

Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water.

Dietary Supplement: Beta-glucan

Galactooligosaccharides

EXPERIMENTAL

Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water.

Dietary Supplement: Galactooligosaccharides

Interventions

Maltodextrin DIETARY_SUPPLEMENT

NOVAPRODUKT, white powder 5 weeks intervention

Maltodextrin

Inulin DIETARY_SUPPLEMENT

BENEO-Orafti, white powder 5 weeks intervention

Inulin

Pectin DIETARY_SUPPLEMENT

BANG \& BONSOMER GROUP OY, white powder 5 weeks intervention

Pectin

Beta-glucan DIETARY_SUPPLEMENT

Tate \& Lyle, white powder 5 weeks intervention

Beta-glucan

Galactooligosaccharides DIETARY_SUPPLEMENT

FrieslandCampina, white powder 5 weeks intervention

Galactooligosaccharides

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas Biomed: lead

Study Sites (1)

Atlas Medical Center

Moscow, Russia

Location

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation; Dyslipidemias

Interventions

maltodextrin; Inulin; Pectins; beta-Glucans

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 3, 2019
• Study Start: November 25, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 30, 2020
• Last Updated: March 12, 2021

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)