NCT04114513

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Atlas Biomed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Maltodextrin	NOVAPRODUKT, white powder 5 weeks intervention
DIETARY_SUPPLEMENT	Inulin	BENEO-Orafti, white powder 5 weeks intervention
DIETARY_SUPPLEMENT	Pectin	BANG \& BONSOMER GROUP OY, white powder 5 weeks intervention
DIETARY_SUPPLEMENT	Beta-glucan	Tate \& Lyle, white powder 5 weeks intervention
DIETARY_SUPPLEMENT	Galactooligosaccharides	FrieslandCampina, white powder 5 weeks intervention

Timeline

• Start date: 2019-11-25
• Primary completion: 2020-09-01
• Completion: 2020-09-30
• First posted: 2019-10-03
• Last updated: 2021-03-12

Locations

1 site across 1 country: Russia