HealthyNCT05421793
Prebiotic and Anti-inflammatory Effects of a Pectin Polysaccharide
A study testing Fermented product of carrot derived rhamnogalacturonan I in people with Healthy, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
The aim of this study is to determine, quantify and understand the potential prebiotic and anti-inflammatory effects of the pecticpolysaccharide rhamnogalacturonan I (RG-I). The effects of these dietary fibre fractions on barrier function will also be investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fermented product of carrot derived rhamnogalacturonan I
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- 6 Jun 2022to 30 Aug 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed consent prior to any study related procedures
- Age 18-65 years
- Willing to abstain from regular consumption of prebiotics/probiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits
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. Irritable Bowel Disease)
- Systemic use of antibiotics or steroids medications in the last 3 months
- Frequent use of NSAID (Non Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
Show all 10Show fewer
- Regular consumption of prebiotic/probiotic products for the past 4 weeks
- Abuse of alcohol or drugs
- Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 12 weeks prior to study visits
- Pregnancy and breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 and anti-inflammatory effects of the pecticpolysaccharide rhamnogalacturonan I (RG-I). The effects of these dietary fibre fractions on barrier function will also be investigated.
Read the detailed description
The dietary fibre fractions from RG-I will be tested first for their prebiotic potential. Batch culture fermentation systems containing basal growth medium will be inoculated with faecal homogenates obtained from different time points (Task I) and will be used for analyzing microbiota composition and microbiota-associated metabolites. Subsequently, the collection of colon biopsies through sigmoidoscopy procedure of the same subjects will take place and the collected biopsies will be mounted in Ussing Chambers. Supernatants collected from Task I will be added to the mucosal side of the biopsy together with a stressor and two permeability markers, in order to investigate the effects of the fibre fractions on both paracellular and transcellular permeability.Throughout the study subjects will complete questionnaires related to their gastrointestinal health and dietary habits
- Conditions
- Healthy
- Being tested
- Fermented product of carrot derived rhamnogalacturonan I
- Keywords
- paracellular permeability, transcellular permability, rhamnogalacturonan I, prebiotic, gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented product of carrot derived rhamnogalacturonan IOther
Stimulation of human colonic biopsies with the fermented product of carrot derived rhamnogalacturonan I
| Study group | Role | What they receive |
|---|---|---|
| Gut barrier function treatments | Experimental | Stressor, fibre, combination of treatments. Receives: Other: Fermented product of carrot derived rhamnogalacturonan I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of barrier function after 90 minutes of ex vivo stimulation of the colonic biopsies.
Barrier function will be evaluated with the use of markers related to paracellular and transcellular permeability, through immunofluoresence and ELISA tecnhique.
Measured: Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies.
Change from baseline to the effect on the intestinal microbial populations and their metabolic products [i.e. Short-Chain Fatty Acids (SCFA)] (prebiotic effect) by the end of the in vitro fermentation process.
Microbial populations will be quantified with 16SRNA sequencing and quantitative Polymerase Chain Reaction (PCR).
SCFAs will be quantified with Gas chromatography.
Measured: The levels of microbial populations and their metabolic products will be measured at baseline and after 6 hours of in vitro fermentation procedure.
Secondary outcomes (4)
Effect of RG-I fractions on immune system reinforcement in the end of the ex vivo stimulation of the colonic biopsies.
Selected pro- and anti- inflammatory cytokines levels will be measured on the colonic biopsies tissues by ELISA techniques.
Measured: Immune system reinforcement will be evaluated after 90 minutes of ex vivo stimulation of the colonic biopsies.
Gastrointestinal health status prior to the initiation of the study.
Gastrointestinal health will be evaluated once with the use of a 1-day questionnaire consisting of 13 items concerning satiety, abdominal pain, diarrhoea, 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 health will be measured at baseline prior to the initiation of the study as background information.
Dietary intake prior to the initiation of the study.
Dietary intake will be evaluated with the use of 3-days diet intake records.
Measured: Dietary intake will be measured at baseline prior to the initiation of the study as background information.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start6 Jun 2022
- Primary completion30 Jul 2023
- Study completion30 Aug 2023
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- NutriLeads B.V. (Wageningen, The Netherlands)
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
- Investigators
- Robert Brummer, Professor, Principal investigator, Örebro University, School of Medical Sciences, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421793
- Sponsor's protocol ID
- 2022-01814-02
- Status last verified
- Sep 2023
- First submitted
- 7 Jun 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. 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
- NCT05421793
- Acronym / sponsor ID
- 2022-01814-02
- Conditions
- Healthy
- Keywords
- paracellular permeability, transcellular permability, rhamnogalacturonan I, prebiotic, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- NutriLeads B.V. (Wageningen, The Netherlands)
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 16 Jun 2022 (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.
The aim of this study is to determine, quantify and understand the potential prebiotic and anti-inflammatory effects of the pecticpolysaccharide rhamnogalacturonan I (RG-I). The effects of these dietary fibre fractions on barrier function will also be investigated.
Detailed description
The dietary fibre fractions from RG-I will be tested first for their prebiotic potential. Batch culture fermentation systems containing basal growth medium will be inoculated with faecal homogenates obtained from different time points (Task I) and will be used for analyzing microbiota composition and microbiota-associated metabolites. Subsequently, the collection of colon biopsies through sigmoidoscopy procedure of the same subjects will take place and the collected biopsies will be mounted in Ussing Chambers. Supernatants collected from Task I will be added to the mucosal side of the biopsy together with a stressor and two permeability markers, in order to investigate the effects of the fibre fractions on both paracellular and transcellular permeability.Throughout the study subjects will complete questionnaires related to their gastrointestinal health and dietary habits
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gut barrier function treatments | Experimental | Other: Fermented product of carrot derived rhamnogalacturonan IStressor, fibre, combination of treatments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed consent prior to any study related procedures
- Age 18-65 years
- Willing to abstain from regular consumption of prebiotics/probiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits
Key exclusion criteria (10 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. Irritable Bowel Disease)
- Systemic use of antibiotics or steroids medications in the last 3 months
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 |
|---|---|---|
| Fermented product of carrot derived rhamnogalacturonan IStimulation of human colonic biopsies with the fermented product of carrot derived rhamnogalacturonan I | Other | Gut barrier function treatments |
Primary outcome
Change from baseline of barrier function after 90 minutes of ex vivo stimulation of the colonic biopsies.
Time frame: Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies.
Barrier function will be evaluated with the use of markers related to paracellular and transcellular permeability, through immunofluoresence and ELISA tecnhique.
Change from baseline to the effect on the intestinal microbial populations and their metabolic products [i.e. Short-Chain Fatty Acids (SCFA)] (prebiotic effect) by the end of the in vitro fermentation process.
Time frame: The levels of microbial populations and their metabolic products will be measured at baseline and after 6 hours of in vitro fermentation procedure.
Microbial populations will be quantified with 16SRNA sequencing and quantitative Polymerase Chain Reaction (PCR). SCFAs will be quantified with Gas chromatography.
4 secondary outcomes
Effect of RG-I fractions on immune system reinforcement in the end of the ex vivo stimulation of the colonic biopsies.
Time frame: Immune system reinforcement will be evaluated after 90 minutes of ex vivo stimulation of the colonic biopsies.
Gastrointestinal health status prior to the initiation of the study.
Time frame: Gastrointestinal health will be measured at baseline prior to the initiation of the study as background information.
Dietary intake prior to the initiation of the study.
Time frame: Dietary intake will be measured at baseline prior to the initiation of the study as background information.
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.
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 21 Sep 2023.
- Research center websiteLink provided by the sponsor.
- 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.
Robert Brummer, Professor principal investigator
Örebro University, School of Medical Sciences, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented product of carrot derived rhamnogalacturonan 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 3 inclusion and 10 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 21 Sep 2023. 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. 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 of barrier function after 90 minutes of ex vivo stimulation of the colonic biopsies. (time frame: Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies.). 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?
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 21 Sep 2023.