Microbiome, Metabolic Syndrome, Cardiovascular Risk Factor, Inflammation, Dyslipidemias
Conditions
Keywords
Dietary fiber, Gut Microbiota, Cardiovascular risk factors, Lipid metabolism
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).
Interventions
DIETARY_SUPPLEMENTMaltodextrin
NOVAPRODUKT, white powder 5 weeks intervention
DIETARY_SUPPLEMENTInulin
BENEO-Orafti, white powder 5 weeks intervention
DIETARY_SUPPLEMENTPectin
BANG & BONSOMER GROUP OY, white powder 5 weeks intervention
DIETARY_SUPPLEMENTBeta-glucan
Tate & Lyle, white powder 5 weeks intervention
DIETARY_SUPPLEMENTGalactooligosaccharides
FrieslandCampina, white powder 5 weeks intervention
Sponsors
Atlas Biomed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood lipids levels | Change from Baseline Blood lipids levels at 5th week | LDL, HDL, TC, TG, apoB, Lp(a) |
| Change in Gut microbiota composition | Change from Baseline at 5th week | Relative abundance of bacterial taxa according to 16S rRNA sequencing data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stool consistency | Change from Baseline at 5th week | The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. |
| Change in Stool frequency | Change from Baseline at 5th week | 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 Fecal short-chain fatty acids | Change from Baseline at 5th week | Butyrate, propionate and acetate concentrations |
| Change in Quality of Life: SF-36 questionnaire | Change from Baseline at 5th week | 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 | Change from Baseline at 5th week | 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 in Body Composition | Baseline and 5th week | Bioelectrical impedance analysis |
| Change in High sensitive C-reactive protein | Change from Baseline at 5th week | Low-grade inflammation assessment |
Countries
Russia
Outcome results
None listed