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

NCT06081972 | Completed

• 1 other identifier: 2023-03938-01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

prebiotic; short - chain fatty acids (SCFAs); Plasmacytoid dendritic cell markers (PDCs); gut microbiota; rhamnogalacturonan I; immune response

Outcome Measures

Primary Outcomes (2)

• Change from baseline to the effect on selected intestinal microbial populations.

  Selected microbial populations will be quantified with quantitative Polymerase Chain Reaction (PCR).

  The levels of the selected microbial populations will be measured weekly from baseline till the end of the interventional period.(4 weeks period)

• Change from baseline to the effect on the intestinal microbial populations.

  Microbial populations will be quantified with 16SRNA sequencing.

  The levels of the microbial populations will be measured weekly from baseline till the end of the interventional period.(4 weeks period)

Secondary Outcomes (9)

• Change from baseline to the effect on the intestinal microbial populations's metabolic products [i.e. Short-Chain Fatty Acids (SCFA)].

  SCFAs levels will be evaluated at baseline and at the end of the intervention. (4 weeks period)

• Change from baseline to the effect on immune system reinforcement.

  Immune system reinforcement will be evaluated at baseline and at the end of the intervention. (4 weeks period)

• Change from baseline to the effect on inflammation.

  Inflammation will be evaluated at baseline and at the end of the intervention. (4 weeks period)

• Change from baseline to the effect on exhaled volatile organic compounds levels.

  Exhaled volatile organic compounds levels will be evaluated at baseline and at the end of the intervention. (4 weeks period)

• Change from baseline to the effect on fecal metabolomic fingerprinting.

  Metabolomic fingerprinting will be evaluated at baseline and at the end of the intervention. (4 weeks period)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Maltodextrin

Chicory RG-I

EXPERIMENTAL

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

Dietary Supplement: Chicory RG-I

Carrot RG-I

EXPERIMENTAL

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

Dietary Supplement: Carrot RG-I

Interventions

Maltodextrin 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.

Placebo

Chicory RG-I 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.

Chicory RG-I

Carrot RG-I 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.

Carrot RG-I

Eligibility Criteria

• Age: 18 Years - 70 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 18-70 years
• 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
• Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg m-2

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. Inflammatory Bowel Disease)
• Systemic use of antibiotics or steroids medications in the last 3 months prior to study visits
• Frequent use of NSAID (Non-Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
• Abuse of alcohol or drugs
• Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 3 months prior to study visits
• Pregnancy and breast-feeding
• Vegan dietary habits or consumption of dietary fibers ≥ 25 g per day according to the food frequency questionnaire
• Smoking or usage of snus within last 3 months prior to study visits
• No recent weight loss or gain 5% of their normal weight in the last month

Sponsors & Collaborators

• Örebro University, Sweden: lead
• NutriLeads B.V. (Wageningen, The Netherlands): collaborator
• ProDigest (Ghent, Belgium): collaborator
• Ambiotis (Toulouse, France): collaborator

Study Sites (1)

Campus USÖ

Örebro, 703 62, Sweden

Location

MeSH Terms

Interventions

maltodextrin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 13, 2023
• Study Start: October 2, 2023
• Primary Completion: May 30, 2024
• Study Completion: December 31, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)