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

NCT ID: NCT06081972

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Participants who will be randomized in the placebo group will receive maltodextrin (500mg/day).

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

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.

Chicory RG-I

Participants who will be randomized in the placebo group will receive Chicory RG-I (500mg/day).

Group Type: EXPERIMENTAL

Chicory RG-I

Intervention Type: DIETARY_SUPPLEMENT

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.

Carrot RG-I

Participants who will be randomized in the placebo group will receive Carrot RG-I (500mg/day).

Group Type: EXPERIMENTAL

Carrot RG-I

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Signed consent prior to any study related procedures

2. Age 18-70 years

3. Willing to abstain from regular consumption of prebiotics/probiotics/synbiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits

4. Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg m-2

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. Inflammatory Bowel Disease)

5. Systemic use of antibiotics or steroids medications in the last 3 months prior to study visits

6. Frequent use of NSAID (Non-Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits

7. Abuse of alcohol or drugs

8. Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 3 months prior to study visits

9. Pregnancy and breast-feeding

10. Vegan dietary habits or consumption of dietary fibers ≥ 25 g per day according to the food frequency questionnaire

11. Smoking or usage of snus within last 3 months prior to study visits

12. No recent weight loss or gain 5% of their normal weight in the last month

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NutriLeads B.V. (Wageningen, The Netherlands)

UNKNOWN

Sponsor Role: collaborator

ProDigest (Ghent, Belgium)

UNKNOWN

Sponsor Role: collaborator

Ambiotis (Toulouse, France)

UNKNOWN

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Robert Brummer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Campus USÖ

Örebro, , Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2023-03938-01

Identifier Type: -

Identifier Source: org_study_id