Clinical trial NCT05421793: Prebiotic and Anti-inflammatory Effects of a Pectin Polysaccharide
Official title: Towards a Food Ingredient Clinically Proven to Benefit Gut Health: Novel RG-I Variants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: paracellular permeability
transcellular permability
rhamnogalacturonan I
prebiotic
gut microbiota
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: NutriLeads B.V. (Wageningen, The Netherlands)
First posted: 2022-06-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to determine, quantify and understand the potential prebiotic and anti-inflammatory effects of the pecticpolysaccharide rhamnogalacturonan I (RG-I). The effects of these dietary fibre fractions on barrier function will also be investigated.

Detailed description: The dietary fibre fractions from RG-I will be tested first for their prebiotic potential. Batch culture fermentation systems containing basal growth medium will be inoculated with faecal homogenates obtained from different time points (Task I) and will be used for analyzing microbiota composition and microbiota-associated metabolites. Subsequently, the collection of colon biopsies through sigmoidoscopy procedure of the same subjects will take place and the collected biopsies will be mounted in Ussing Chambers. Supernatants collected from Task I will be added to the mucosal side of the biopsy together with a stressor and two permeability markers, in order to investigate the effects of the fibre fractions on both paracellular and transcellular permeability.Throughout the study subjects will complete questionnaires related to their gastrointestinal health and dietary habits

Eligibility criteria: Inclusion Criteria:

1. Signed consent prior to any study related procedures
2. Age 18-65 years
3. Willing to abstain from regular consumption of prebiotics/probiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits

Exclusion Criteria:

1. Previous complicated gastrointestinal surgery
2. Presence of gastrointestinal disorder or any disorder which the principal investigator considers to affect the results of the study
3. Current diagnosis of psychiatric disease
4. Current and past diagnosis inflammatory gastrointestinal disease (e.g. Irritable Bowel Disease)
5. Systemic use of antibiotics or steroids medications in the last 3 months
6. Frequent use of NSAID (Non Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
7. Regular consumption of prebiotic/probiotic products for the past 4 weeks
8. Abuse of alcohol or drugs
9. Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 12 weeks prior to study visits
10. Pregnancy and breast-feeding

Primary outcomes:
measure: Change from baseline of barrier function after 90 minutes of ex vivo stimulation of the colonic biopsies.
timeFrame: Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies.
measure: Change from baseline to the effect on the intestinal microbial populations and their metabolic products [i.e. Short-Chain Fatty Acids (SCFA)] (prebiotic effect) by the end of the in vitro fermentation process.
timeFrame: The levels of microbial populations and their metabolic products will be measured at baseline and after 6 hours of in vitro fermentation procedure.
Secondary outcomes:
measure: Effect of RG-I fractions on immune system reinforcement in the end of the ex vivo stimulation of the colonic biopsies.
timeFrame: Immune system reinforcement will be evaluated after 90 minutes of ex vivo stimulation of the colonic biopsies.
measure: Gastrointestinal health status prior to the initiation of the study.
timeFrame: Gastrointestinal health will be measured at baseline prior to the initiation of the study as background information.
measure: Dietary intake prior to the initiation of the study.
timeFrame: Dietary intake will be measured at baseline prior to the initiation of the study as background information.
measure: Dietary habits prior to the initiation of the study.
timeFrame: Dietary habits will be measured at baseline prior to the initiation of the study as background information.
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Campus USÖ
Study officials:
affiliation: Örebro University, School of Medical Sciences, Sweden
name: Robert Brummer, Professor
role: PRINCIPAL_INVESTIGATOR
References: