Prebiotic and Anti-inflammatory Effects of a Pectin Polysaccharide

NCT05421793 | Completed

• 1 other identifier: 2022-01814-02
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

paracellular permeability; transcellular permability; rhamnogalacturonan I; prebiotic; gut microbiota

Outcome Measures

Primary Outcomes (2)

• Change from baseline of barrier function after 90 minutes of ex vivo stimulation of the colonic biopsies.

  Barrier function will be evaluated with the use of markers related to paracellular and transcellular permeability, through immunofluoresence and ELISA tecnhique.

  Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies.

• 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.

  Microbial populations will be quantified with 16SRNA sequencing and quantitative Polymerase Chain Reaction (PCR). SCFAs will be quantified with Gas chromatography.

  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 (4)

• Effect of RG-I fractions on immune system reinforcement in the end of the ex vivo stimulation of the colonic biopsies.

  Immune system reinforcement will be evaluated after 90 minutes of ex vivo stimulation of the colonic biopsies.

• Gastrointestinal health status prior to the initiation of the study.

  Gastrointestinal health will be measured at baseline prior to the initiation of the study as background information.

• Dietary intake prior to the initiation of the study.

  Dietary intake will be measured at baseline prior to the initiation of the study as background information.

• Dietary habits prior to the initiation of the study.

  Dietary habits will be measured at baseline prior to the initiation of the study as background information.

Study Arms (1)

Gut barrier function treatments

EXPERIMENTAL

Stressor, fibre, combination of treatments.

Other: Fermented product of carrot derived rhamnogalacturonan I

Interventions

Fermented product of carrot derived rhamnogalacturonan I OTHER

Stimulation of human colonic biopsies with the fermented product of carrot derived rhamnogalacturonan I

Gut barrier function treatments

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed consent prior to any study related procedures
• Age 18-65 years
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Örebro University, Sweden: lead
• NutriLeads B.V. (Wageningen, The Netherlands): collaborator

Study Sites (1)

Campus USÖ

Örebro, 703 62, Sweden

Location

Related Links

• Research center website

Study Officials

• Robert Brummer, Professor

  Örebro University, School of Medical Sciences, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 16, 2022
• Study Start: June 6, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)