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

Örebro University, Sweden

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Carrot RG-I; Dietary Supplement: Maltodextrin; Dietary Supplement: Chicory RG-I

Study type: Interventional

Funder types: Other

Identifiers

NCT06081972

2023-03938-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signed consent prior to any study related procedures
2. Age 18-70 years
3. 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
4. Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg m-2

Exclusion criteria

1. Previous complicated gastrointestinal surgery
2. Presence of gastrointestinal disorder or any disorder which the principal investigator considers to affect the results of the study
3. Current diagnosis of psychiatric disease
4. Current and past diagnosis inflammatory gastrointestinal disease (e.g. Inflammatory Bowel Disease)
5. Systemic use of antibiotics or steroids medications in the last 3 months prior to study visits
6. Frequent use of NSAID (Non-Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
7. Abuse of alcohol or drugs
8. Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 3 months prior to study visits
9. Pregnancy and breast-feeding
10. Vegan dietary habits or consumption of dietary fibers ≥ 25 g per day according to the food frequency questionnaire
11. Smoking or usage of snus within last 3 months prior to study visits
12. No recent weight loss or gain 5% of their normal weight in the last month

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Maltodextrin

Chicory RG-I

Experimental group

Description:

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

Treatment:

Dietary Supplement: Chicory RG-I

Carrot RG-I

Experimental group

Description:

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

Treatment:

Dietary Supplement: Carrot RG-I