- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06081972
Towards a Food Ingredient Clinically Proven to Benefit Gut Health: Novel RG-I Variants (NUTRIGUT)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Örebro, Sweden, 703 62
- Recruiting
- Campus USÖ
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Contact:
- Ignacio Rangel, As.Professor
- Phone Number: +46-0701040757
- Email: ignacio.rangel@oru.se
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Sub-Investigator:
- Evangelia Kerezoudi, PhD student
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Participants who will be randomized in the placebo group will receive maltodextrin (500mg/day).
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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.
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Experimental: Chicory RG-I
Participants who will be randomized in the placebo group will receive Chicory RG-I (500mg/day).
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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.
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Experimental: Carrot RG-I
Participants who will be randomized in the placebo group will receive Carrot RG-I (500mg/day).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Selected microbial populations will be quantified with quantitative Polymerase Chain Reaction (PCR).
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The levels of the selected microbial populations will be measured weekly from baseline till the end of the interventional period.(4 weeks period)
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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)
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Microbial populations will be quantified with 16SRNA sequencing.
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The levels of the microbial populations will be measured weekly from baseline till the end of the interventional period.(4 weeks period)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Dietary habits will be evaluated with the use of food frequency questionnaire (FFQ).
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Dietary habits will be measured at baseline prior to the initiation of the study as background information.
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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)
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SCFAs will be quantified with Gas chromatography.
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SCFAs levels will be evaluated at baseline and at the end of the intervention. (4 weeks period)
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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)
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Plasmacytoid dendritic cells activation will be evaluated with flow cytometry.
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Immune system reinforcement will be evaluated at baseline and at the end of the intervention. (4 weeks period)
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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)
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Inflammatory related markers will be quantified by ELISA techniques.
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Inflammation will be evaluated at baseline and at the end of the intervention. (4 weeks period)
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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)
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Exhaled volatile organic compounds levels will be evaluated with Thermal Desorption Gas chromatography.
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Exhaled volatile organic compounds levels will be evaluated at baseline and at the end of the intervention. (4 weeks period)
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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)
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Metabolomic fingerprinting will be evaluated by applying laser assisted Rapid Evaporative Ionisation Mass Spectrometry (LA-REIMS) method on biological material.
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Metabolomic fingerprinting will be evaluated at baseline and at the end of the intervention. (4 weeks period)
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Gastrointestinal tolerance of the supplement.
Time Frame: Gastrointestinal symptoms will be evaluated at baseline and at the end of the intervention. (4 weeks period)
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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.
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Gastrointestinal symptoms will be evaluated at baseline and at the end of the intervention. (4 weeks period)
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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)
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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.
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Physical activity will be evaluated at baseline and at the end of the intervention. (4 weeks period)
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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)
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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).
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Quality of life will be evaluated at baseline and at the end of the intervention. (4 weeks period)
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023-03938-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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