NCT06081972

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Örebro University, Sweden · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to determine, quantify and understand the potential prebiotic effects of RG-I variants via microbiota modulation. The anti-inflammatory potential effects of these variants will also be investigated.

Detailed description

The plant cell wall derived RG-I (from chicory or carrot) and maltodextrin (placebo) in capsuled form will be provided by the food company NutriLeads B.V (Wageningen, The Netherlands), which has run tests of safety of the products and warranties their food grade quality and safety. The administration of RG-I will be done via a human intervention study of parallel arms, randomized, placebo - controlled, double blinded design (proof of concept study). The dietary fibre from different RG-I sources will be tested for its prebiotic and immunomodulatory potential. Thus, the effects of these fibres on short chain fatty acid (SCFA) profile, microbiota composition, microbiota-associated metabolites and intestinal inflammatory markers will be investigated from fecal material obtained from the study participants. The dietary fibre from different RG-I sources will be tested for their immunomodulatory and lifestyle related effects. The effects of fibres on immune activation markers will be investigated from blood samples collected from the study participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Maltodextrin	During the feeding period (4 weeks) two capsules/ day will be administered to subjects randomized in this group containing placebo powder with a breakfast item on a daily basis.
DIETARY_SUPPLEMENT	Chicory RG-I	During the feeding period (4 weeks) two capsules/ day will be administered to subjects randomized in this group containing chicory RG-I with a breakfast item on a daily basis.
DIETARY_SUPPLEMENT	Carrot RG-I	During the feeding period (4 weeks) two capsules/ day will be administered to subjects randomized in this group containing carrot RG-I with a breakfast item on a daily basis.

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-05-30
• Completion: 2024-12-31
• First posted: 2023-10-13
• Last updated: 2025-07-16

Locations

1 site across 1 country: Sweden