Dietary Fibers Effect on the Gut Microbiota Composition

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04114513
• Other study ID #: DFI
• Status: Withdrawn
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2019
• Source: Atlas Biomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• HbA1? 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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Maltodextrin
NOVAPRODUKT, white powder 5 weeks intervention
• Inulin
BENEO-Orafti, white powder 5 weeks intervention
• Pectin
BANG & BONSOMER GROUP OY, white powder 5 weeks intervention
• Beta-glucan
Tate & Lyle, white powder 5 weeks intervention
• Galactooligosaccharides
FrieslandCampina, white powder 5 weeks intervention

Locations

Country	Name	City	State
Russian Federation	Atlas Medical Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Atlas Biomed

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood lipids levels	LDL, HDL, TC, TG, apoB, Lp(a)	Change from Baseline Blood lipids levels at 5th week
Primary	Change in Gut microbiota composition	Relative abundance of bacterial taxa according to 16S rRNA sequencing data	Change from Baseline at 5th week
Secondary	Change in Fecal short-chain fatty acids	Butyrate, propionate and acetate concentrations	Change from Baseline at 5th week
Secondary	Change in High sensitive C-reactive protein	Low-grade inflammation assessment	Change from Baseline at 5th week
Secondary	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
Secondary	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
Secondary	Change in Body Composition	Bioelectrical impedance analysis	Baseline and 5th week
Secondary	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
Secondary	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