Testing a new food ingredient for gut health benefits
Towards a Food Ingredient Clinically Proven to Benefit Gut Health: Novel RG-I Variants
This study is testing a new food ingredient made from chicory and carrot to see if it can improve gut health for people who participate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Örebro University, Sweden Academic / other |
| Locations | 2 sites (Örebro and 1 other locations) |
| Trial ID | NCT06081972 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the prebiotic effects of novel RG-I variants derived from chicory and carrot on gut health. Participants will receive either RG-I or a placebo in a randomized, double-blind, placebo-controlled design. The study will assess changes in gut microbiota, short-chain fatty acid profiles, and inflammatory markers through fecal and blood samples. The goal is to understand how these dietary fibers can modulate gut health and immune responses.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-70 with a BMI between 18.5 and 30.0 who can abstain from prebiotic and probiotic products prior to the study.
Not a fit: Patients with gastrointestinal disorders, psychiatric diseases, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new dietary interventions that improve gut health and reduce inflammation.
How similar studies have performed: While the specific RG-I variants are novel, similar studies have shown promise in using dietary fibers to modulate gut health.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Örebro and 1 other locations
- Campus USÖ — Örebro, Sweden (Recruiting)
- Campus USÖ — Örebro, Sweden (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.