Dietary Fibers Effect on the Gut Microbiota Composition

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

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

Study Overview

• Status: Withdrawn
• Conditions: Inflammation; Metabolic Syndrome; Dyslipidemias; Cardiovascular Risk Factor; Microbiome
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: Inulin; Dietary supplement: Pectin; Dietary supplement: Beta-glucan; Dietary supplement: Galactooligosaccharides

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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Atlas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Maltodextrin; 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; NOVAPRODUKT, white powder 5 weeks intervention
Experimental: Inulin; 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; BENEO-Orafti, white powder 5 weeks intervention
Experimental: Pectin; 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; BANG & BONSOMER GROUP OY, white powder 5 weeks intervention
Experimental: Beta-glucan; 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; Tate & Lyle, white powder 5 weeks intervention
Experimental: Galactooligosaccharides; 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; FrieslandCampina, white powder 5 weeks intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fecal short-chain fatty acids	Butyrate, propionate and acetate concentrations	Change from Baseline at 5th week
Change in High sensitive C-reactive protein	Low-grade inflammation assessment	Change from Baseline at 5th week
Change in Stool consistency	The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories.	Change from Baseline at 5th week
Change in Stool frequency	Rome criteria questionnaire. The Rome IV criteria for the diagnosis of irritable bowel syndrome require that patients have had recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with two or more of the following : Related to defecation (may be increased or unchanged by defecation)	Change from Baseline at 5th week
Change in Body Composition	Bioelectrical impedance analysis	Baseline and 5th week
Change in Quality of Life: SF-36 questionnaire	According to SF-36 questionnaire The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) It is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively	Change from Baseline at 5th week
Change in Psychological distress	Hospital Anxiety and Depression Scale (HADS) Patients anxiety and depression will be assessed using the HADS : Hospital Anxiety and Depression scale. Scores of the HADS scale can be defined as: By adding the points of the answers: 1, 3, 5, 7, 9, 11, 13: we obtain the "Total A" which corresponds to the measure of the anxiety, then: 7 or less: absence of symptomatology; 8 to 10: doubtful symptomatology; 11 and above: certain symptomatology. By adding the points of the answers: 2, 4, 6, 8, 10, 12, 14: we obtain the "Total B" which corresponds to the measure of the depression, then: 7 or less: absence of symptomatology; 8 to 10: doubtful symptomatology; 11 and above: certain symptomatology. The minimal score is 0 and the maximal total score is 42.	Change from Baseline at 5th week

Collaborators and Investigators

• Sponsor: Atlas Biomed

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Gut Microbiota; Dietary fiber; Lipid metabolism; Cardiovascular risk factors
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Inflammation; Metabolic Syndrome; Dyslipidemias
• Other Study ID Numbers: DFI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No