Status:
COMPLETED
Towards a Food Ingredient Clinically Proven to Benefit Gut Health: Novel RG-I Variants
Lead Sponsor:
Örebro University, Sweden
Collaborating Sponsors:
NutriLeads B.V. (Wageningen, The Netherlands)
ProDigest (Ghent, Belgium)
Conditions:
Healthy
Eligibility:
All Genders
18-70 years
Phase:
NA
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 wil...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT06081972
Start Date
October 2 2023
End Date
December 31 2024
Last Update
July 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Campus USÖ
Örebro, Sweden, 703 62