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Dietary Fibers Effect on the Gut Microbiota Composition

Primary Purpose

Microbiome, Metabolic Syndrome, Cardiovascular Risk Factor

Status
Withdrawn
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Maltodextrin
Inulin
Pectin
Beta-glucan
Galactooligosaccharides
Sponsored by
Atlas Biomed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Microbiome focused on measuring Dietary fiber, Gut Microbiota, Cardiovascular risk factors, Lipid metabolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Atlas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Maltodextrin

Inulin

Pectin

Beta-glucan

Galactooligosaccharides

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Blood lipids levels
LDL, HDL, TC, TG, apoB, Lp(a)
Change in Gut microbiota composition
Relative abundance of bacterial taxa according to 16S rRNA sequencing data

Secondary Outcome Measures

Change in Fecal short-chain fatty acids
Butyrate, propionate and acetate concentrations
Change in High sensitive C-reactive protein
Low-grade inflammation assessment
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 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 in Body Composition
Bioelectrical impedance analysis
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 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.

Full Information

First Posted
September 27, 2019
Last Updated
March 10, 2021
Sponsor
Atlas Biomed
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1. Study Identification

Unique Protocol Identification Number
NCT04114513
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19 lockdown
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atlas Biomed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbiome, Metabolic Syndrome, Cardiovascular Risk Factor, Inflammation, Dyslipidemias
Keywords
Dietary fiber, Gut Microbiota, Cardiovascular risk factors, Lipid metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Inulin
Arm Type
Experimental
Arm Description
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.
Arm Title
Pectin
Arm Type
Experimental
Arm Description
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.
Arm Title
Beta-glucan
Arm Type
Experimental
Arm Description
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.
Arm Title
Galactooligosaccharides
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
NOVAPRODUKT, white powder 5 weeks intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin
Intervention Description
BENEO-Orafti, white powder 5 weeks intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Pectin
Intervention Description
BANG & BONSOMER GROUP OY, white powder 5 weeks intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-glucan
Intervention Description
Tate & Lyle, white powder 5 weeks intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Galactooligosaccharides
Intervention Description
FrieslandCampina, white powder 5 weeks intervention
Primary Outcome Measure Information:
Title
Blood lipids levels
Description
LDL, HDL, TC, TG, apoB, Lp(a)
Time Frame
Change from Baseline Blood lipids levels at 5th week
Title
Change in Gut microbiota composition
Description
Relative abundance of bacterial taxa according to 16S rRNA sequencing data
Time Frame
Change from Baseline at 5th week
Secondary Outcome Measure Information:
Title
Change in Fecal short-chain fatty acids
Description
Butyrate, propionate and acetate concentrations
Time Frame
Change from Baseline at 5th week
Title
Change in High sensitive C-reactive protein
Description
Low-grade inflammation assessment
Time Frame
Change from Baseline at 5th week
Title
Change in Stool consistency
Description
The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories.
Time Frame
Change from Baseline at 5th week
Title
Change in Stool frequency
Description
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)
Time Frame
Change from Baseline at 5th week
Title
Change in Body Composition
Description
Bioelectrical impedance analysis
Time Frame
Baseline and 5th week
Title
Change in Quality of Life: SF-36 questionnaire
Description
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
Time Frame
Change from Baseline at 5th week
Title
Change in Psychological distress
Description
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.
Time Frame
Change from Baseline at 5th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Atlas Medical Center
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Dietary Fibers Effect on the Gut Microbiota Composition

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