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

Sponsor

Örebro University, Sweden (Other)

Overall Status

Recruiting

CT.gov ID

NCT06081972

Collaborator

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

Enrollment

Locations

Arms

Anticipated Duration (Months)

37.5

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Maltodextrin Dietary Supplement: Chicory RG-I Dietary Supplement: Carrot RG-I	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 2, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants who will be randomized in the placebo group will receive maltodextrin (500mg/day).	Dietary Supplement: Maltodextrin 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.
Experimental: Chicory RG-I Participants who will be randomized in the placebo group will receive Chicory RG-I (500mg/day).	Dietary Supplement: Chicory RG-I 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.
Experimental: Carrot RG-I Participants who will be randomized in the placebo group will receive Carrot RG-I (500mg/day).	Dietary Supplement: Carrot RG-I 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.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

Dietary Supplement: Maltodextrin

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.

Experimental: Chicory RG-I

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

Dietary Supplement: Chicory RG-I

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.

Experimental: Carrot RG-I

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

Dietary Supplement: Carrot RG-I

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.

Outcome Measures

Primary Outcome Measures

Change from baseline to the effect on selected intestinal microbial populations. [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. [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 Outcome Measures

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)]
SCFAs will be quantified with Gas chromatography.
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)]
Plasmacytoid dendritic cells activation will be evaluated with flow cytometry.
Change from baseline to the effect on inflammation. [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.
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)]
Exhaled volatile organic compounds levels will be evaluated with Thermal Desorption Gas chromatography.
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)]
Metabolomic fingerprinting will be evaluated by applying laser assisted Rapid Evaporative Ionisation Mass Spectrometry (LA-REIMS) method on biological material.
Gastrointestinal tolerance of the supplement. [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.
Dietary habits prior to the initiation of the study. [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).
Changes from baseline to the effect on physical activity levels. [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.
Changes from baseline to the effect on quality of life. [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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