HealthyNUTRIGUTNCT06081972

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

A study testing Maltodextrin, Chicory RG-I and Carrot RG-I in people with Healthy, run by Örebro University, Sweden at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Maltodextrin, Chicory RG-I and Carrot RG-I
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 1 siteSweden
Study dates: 2 Oct 2023to 31 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Campus USÖ
Örebro, 703 62

Other trials in Sweden

About this study

Read the 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
Being tested: Maltodextrin, Chicory RG-I, Carrot RG-I
Keywords: prebiotic, short - chain fatty acids (SCFAs), Plasmacytoid dendritic cell markers (PDCs), gut microbiota, rhamnogalacturonan I, immune response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MaltodextrinDietary 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-IDietary 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-IDietary 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.

Study groups in NCT06081972
Study group	Role	What they receive
Placebo	Placebo comparator	Participants who will be randomized in the placebo group will receive maltodextrin (500mg/day). Receives: Dietary Supplement: Maltodextrin
Chicory RG-I	Experimental	Participants who will be randomized in the placebo group will receive Chicory RG-I (500mg/day). Receives: 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). Receives: Dietary Supplement: Carrot RG-I

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline to the effect on selected intestinal microbial populations.
Selected microbial populations will be quantified with quantitative Polymerase Chain Reaction (PCR).
Measured: 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.
Measured: 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 will be quantified with Gas chromatography.
Measured: 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.
Plasmacytoid dendritic cells activation will be evaluated with flow cytometry.
Measured: 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.
Inflammatory related markers will be quantified by ELISA techniques.
Measured: 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 with Thermal Desorption Gas chromatography.
Measured: 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 by applying laser assisted Rapid Evaporative Ionisation Mass Spectrometry (LA-REIMS) method on biological material.
Measured: Metabolomic fingerprinting will be evaluated at baseline and at the end of the intervention. (4 weeks period)
Gastrointestinal tolerance of the supplement.
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.
Measured: Gastrointestinal symptoms will be evaluated at baseline and at the end of the intervention. (4 weeks period)
Dietary habits prior to the initiation of the study.
Dietary habits will be evaluated with the use of food frequency questionnaire (FFQ).
Measured: Dietary habits will be measured at baseline prior to the initiation of the study as background information.
Changes from baseline to the effect on physical activity levels.
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.
Measured: Physical activity will be evaluated at baseline and at the end of the intervention. (4 weeks period)
Changes from baseline to the effect on quality of life.
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).
Measured: Quality of life will be evaluated at baseline and at the end of the intervention. (4 weeks period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Oct 202331 Dec 2024

First posted13 Oct 2023
Study start2 Oct 2023
Primary completion30 May 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06081972
Sponsor's protocol ID: 2023-03938-01
Other IDs: 2023
Acronym: NUTRIGUT
Status last verified: Jul 2025
First submitted: 20 Sep 2023
Last updated: 16 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Towards a Food Ingredient Clinically Proven to Benefit Gut Health: Novel RG-I Variants
ClinicalTrials.gov ID: NCT06081972
Acronym / sponsor ID: NUTRIGUT / 2023-03938-01
Conditions: Healthy
Keywords: prebiotic, short - chain fatty acids (SCFAs), Plasmacytoid dendritic cell markers (PDCs), gut microbiota, rhamnogalacturonan I, immune response
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Örebro University, SwedenUniversity, hospital or other
Collaborators: NutriLeads B.V. (Wageningen, The Netherlands), ProDigest (Ghent, Belgium), Ambiotis (Toulouse, France)
Study start: 2 Oct 2023 (actual)
Primary completion: 30 May 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 13 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Dietary Supplement: MaltodextrinParticipants who will be randomized in the placebo group will receive maltodextrin (500mg/day).
Chicory RG-I	Experimental	Dietary Supplement: Chicory RG-IParticipants who will be randomized in the placebo group will receive Chicory RG-I (500mg/day).
Carrot RG-I	Experimental	Dietary Supplement: Carrot RG-IParticipants who will be randomized in the placebo group will receive Carrot RG-I (500mg/day).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MaltodextrinDuring 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	Placebo
Chicory RG-IDuring 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	Chicory RG-I
Carrot RG-IDuring 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.	Dietary supplement	Carrot RG-I

Primary outcome

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).
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.

9 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Maltodextrin, Chicory RG-I and Carrot RG-I in people with Healthy, run by Örebro University, Sweden at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06081972.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.