Towards a Food Ingredient Clinically Proven to Benefit Gut Health: Novel RG-I Variants
Phase: NA
Conditions: Healthy
Sponsor: Örebro University, Sweden

 
 
 
 
 
2022-06-11 
 
 
 
 
 
STUDY WITH TITLE: 
 
“Prebiotic and Anti-inflammatory Effects of a Pectin 
Polysaccharide” 
 
STUDY PROTOCOL 
 
Task 1: Evaluation of prebiotic effects RG-I  
The dietary fibre fractions from RG-I will be tested for their prebiotic potential. Thus, the effects of these fibres 
on short chain fatty acid (SCFA) profile, microbiota composition and microbiota-associated metabolites will be 
investigated. In this Task, batch culture fermentation systems containing basal growth medium will be 
inoculated with faecal homogenates obtained from healthy subjects and RG-I. Samples from the in vitro 
fermentation will be obtained from different time points and will be used for analyzing microbiota composition 
and microbiota-associated metabolites. Subjects will complete validated questionnaires related to their 
dietary intake and a Gastrointestinal Symptom rating scale (GSRS-IBS) in this Task.  
Task 2: Evaluation of the effects of RG-I fractions on intestinal permeability  
By using a sigmoidoscopy procedure, colon biopsies will be collected from the subjects, where the collected 
biopsies will be mounted in Ussing Chambers in order to investigate the effects of the fibre fractions on 
intestinal permeability. Supernatants collected from Task 1 will be added to the mucosal side of the biopsy 
together with a stressor and two permeability markers. Samples will subsequently be collected from the 
serosal side and will be used to measure the permeability markers related to paracellular and transcellular 
permeability.  
 
 
 
 
Ö r e b r o  U n i v e r s i t y  
 
SCHOOL OF MEDICAL SCIENCE 
 
Nutrition -Gut -Brain Interactions Research Centre 
(NGBI) 

 
 
 
 
 
2022-06-11 
 
 
STATISTICAL ANALYSIS 
 
All statistical tests will be assessed using One Way ANOVA with a nominal significance level of 5% and post hoc 
testing of treatment contrasts with Tukey’s HSD. The primary endpoint analysis will be based on fibre effect 
on the intestinal barrier function in terms of FITC passage, and whether there is a difference between 
treatments across all healthy subjects. Secondary endpoints include HRP quantification (supernatant), TEER 
values (electrophysiological parameter).