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Completed

NCT Number: NCT06081972

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 effects of RG-I variants via microbiota modulation. The anti-inflammatory potential effects of these variants will also be investigated.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus USÖ

Örebro, 703 62, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

Primary outcomes

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

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

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

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

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

    Microbial populations will be quantified with 16SRNA sequencing.

Secondary outcomes

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

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

    SCFAs will be quantified with Gas chromatography.

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

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

    Plasmacytoid dendritic cells activation will be evaluated with flow cytometry.

  3. Change from baseline to the effect on inflammation.

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

    Inflammatory related markers will be quantified by ELISA techniques.

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

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

    Exhaled volatile organic compounds levels will be evaluated with Thermal Desorption Gas chromatography.

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

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

    Metabolomic fingerprinting will be evaluated by applying laser assisted Rapid Evaporative Ionisation Mass Spectrometry (LA-REIMS) method on biological material.

  6. Gastrointestinal tolerance of the supplement.

    Time frame: Gastrointestinal symptoms will be evaluated at baseline and at the end of the intervention. (4 weeks period)

    Gastrointestinal health will be evaluated with the use of a 1-day questionnaire consisting of 13 items concerning satiety, abdominal pain, diarrhea, 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.

  7. 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).

  8. Changes from baseline to the effect on physical activity levels.

    Time frame: Physical activity will be evaluated at baseline and at the end of the intervention. (4 weeks period)

    Physical activity will be evaluated with the use of a validated questionnaire. IPAQ consists of 7 items questions concerning the duration and the intensity of physical activity so absolute numerical data will be obtained from it.

  9. Changes from baseline to the effect on quality of life.

    Time frame: Quality of life will be evaluated at baseline and at the end of the intervention. (4 weeks period)

    Quality of life will be evaluated with the use of a validated questionnaire. EQ-5D-5L consists of 5 items concerning mobility, self-care, usual activities, pain/discomfort, anxiety/depression.The overall score from this questionnaire will be calculated by assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 (11,111, no problems on any dimension) to 25 (55,555, extreme problems on all dimensions).

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Ambiotis (Toulouse, France)
  • NutriLeads B.V. (Wageningen, The Netherlands)
  • ProDigest (Ghent, Belgium)

Registry information

Acronym: NUTRIGUT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 13, 2023
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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