Prebiotic and Anti-inflammatory Effects of a Pectin Polysaccharide

September 20, 2023 updated by: Robert Brummer, Örebro University, Sweden

Towards a Food Ingredient Clinically Proven to Benefit Gut Health: Novel RG-I Variants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, 703 62
        • Campus USÖ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gut barrier function treatments
Stressor, fibre, combination of treatments.
Other: Fermented product of carrot derived rhamnogalacturonan I
Stimulation of human colonic biopsies with the fermented product of carrot derived rhamnogalacturonan I

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of barrier function after 90 minutes of ex vivo stimulation of the colonic biopsies.
Time Frame: Barrier function will be measured at baseline and 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.
Time Frame: The levels of microbial populations and their metabolic products will be measured at baseline and after 6 hours of in vitro fermentation procedure.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of RG-I fractions on immune system reinforcement in the end of the ex vivo stimulation of the colonic biopsies.
Time Frame: Immune system reinforcement will be evaluated after 90 minutes of ex vivo stimulation of the colonic biopsies.
Selected pro- and anti- inflammatory cytokines levels will be measured on the colonic biopsies tissues by ELISA techniques.
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.
Time Frame: Gastrointestinal health will be measured at baseline prior to the initiation of the study as background information.
Gastrointestinal health will be evaluated once with the use of a 1-day questionnaire consisting of 13 items concerning satiety, abdominal pain, diarrhoea, constipation and bloating.The intensity of each parameter will be assessed on a scale of 0-7, where '0' represents absence of symptoms and '7' severe symptoms.
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.
Time Frame: Dietary intake will be measured at baseline prior to the initiation of the study as background information.
Dietary intake will be evaluated with the use of 3-days diet intake records.
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.
Time Frame: Dietary habits will be measured at baseline prior to the initiation of the study as background information.
Dietary habits will be evaluated with the use of food frequency questionnaire (FFQ).
Dietary habits will be measured at baseline prior to the initiation of the study as background information.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Örebro University, Sweden

Collaborators

NutriLeads B.V. (Wageningen, The Netherlands)

Investigators

  • Principal Investigator: Robert Brummer, Professor, Örebro University, School of Medical Sciences, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2022

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-01814-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe