An interventional study of Maltodextrin and Inulin in Microbiome, Metabolic Syndrome and Cardiovascular Risk Factor, sponsored by Atlas Biomed. Withdrawn at 1 site in Russian Federation. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-12.
Sponsored by Atlas Biomed · Not applicable, Interventional, and Basic science
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
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).
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Exclusion Criteria:
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
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
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
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
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
NOVAPRODUKT, white powder 5 weeks intervention
BENEO-Orafti, white powder 5 weeks intervention
BANG \& BONSOMER GROUP OY, white powder 5 weeks intervention
Tate \& Lyle, white powder 5 weeks intervention
FrieslandCampina, white powder 5 weeks intervention
Blood lipids levels
LDL, HDL, TC, TG, apoB, Lp(a)
Time frame: 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
Time frame: Change from Baseline at 5th week
Change in Fecal short-chain fatty acids
Butyrate, propionate and acetate concentrations
Time frame: Change from Baseline at 5th week
Change in High sensitive C-reactive protein
Low-grade inflammation assessment
Time frame: 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.
Time frame: 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)
Time frame: Change from Baseline at 5th week
Change in Body Composition
Bioelectrical impedance analysis
Time frame: 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
Time frame: 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.
Time frame: Change from Baseline at 5th week
Plan to share: No
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