Clinical trial NCT06081972: Towards a Food Ingredient Clinically Proven to Benefit Gut Health: Novel RG-I Variants
Official title: Towards a Food Ingredient Clinically Proven to Benefit Gut Health: Novel RG-I Variants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: prebiotic
short - chain fatty acids (SCFAs)
Plasmacytoid dendritic cell markers (PDCs)
gut microbiota
rhamnogalacturonan I
immune response
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: NutriLeads B.V. (Wageningen, The Netherlands)
name: ProDigest (Ghent, Belgium)
name: Ambiotis (Toulouse, France)
First posted: 2023-10-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to the effect on selected intestinal microbial populations.
timeFrame: The levels of the selected microbial populations will be measured weekly from baseline till the end of the interventional period.(4 weeks period)
measure: Change from baseline to the effect on the intestinal microbial populations.
timeFrame: The levels of the microbial populations will be measured weekly from baseline till the end of the interventional period.(4 weeks period)
Secondary outcomes:
measure: Change from baseline to the effect on the intestinal microbial populations's metabolic products [i.e. Short-Chain Fatty Acids (SCFA)].
timeFrame: SCFAs levels will be evaluated at baseline and at the end of the intervention. (4 weeks period)
measure: Change from baseline to the effect on immune system reinforcement.
timeFrame: Immune system reinforcement will be evaluated at baseline and at the end of the intervention. (4 weeks period)
measure: Change from baseline to the effect on inflammation.
timeFrame: Inflammation will be evaluated at baseline and at the end of the intervention. (4 weeks period)
measure: Change from baseline to the effect on exhaled volatile organic compounds levels.
timeFrame: Exhaled volatile organic compounds levels will be evaluated at baseline and at the end of the intervention. (4 weeks period)
measure: Change from baseline to the effect on fecal metabolomic fingerprinting.
timeFrame: Metabolomic fingerprinting will be evaluated at baseline and at the end of the intervention. (4 weeks period)
measure: Gastrointestinal tolerance of the supplement.
timeFrame: Gastrointestinal symptoms will be evaluated at baseline and at the end of the intervention. (4 weeks period)
measure: Dietary habits prior to the initiation of the study.
timeFrame: Dietary habits will be measured at baseline prior to the initiation of the study as background information.
measure: Changes from baseline to the effect on physical activity levels.
timeFrame: Physical activity will be evaluated at baseline and at the end of the intervention. (4 weeks period)
measure: Changes from baseline to the effect on quality of life.
timeFrame: Quality of life will be evaluated at baseline and at the end of the intervention. (4 weeks period)
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Campus USÖ
city: Örebro
country: Sweden
facility: Campus USÖ
Study officials:
References: