Omega-3 fats to reduce inflammation in adults with newly diagnosed celiac disease
Official title: Modulation of Blood and Small Intestinal Inflammatory Processes and Fecal Microbiota in Celiac Disease Associated With the Intake of n-3 Polyunsaturated Fatty Acids
Run by University of Chile · NCT07585669 · Data updated 2026-11-12
This study tests whether adding omega-3 fatty acid supplements to a gluten-free plan helps reduce inflammation and promote intestinal healing in adults who have just been diagnosed with celiac disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Chile Academic / other |
| Locations | 1 site (Santiago, Metropolitan Region) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | October 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07585669 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 who have been newly diagnosed with celiac disease, have not started a gluten-free diet, and are willing to adhere to a supervised gluten-free plan.
✕Probably not a fit
Individuals not experiencing inflammation or intestinal inflammation that responds similarly to diet alone may not see additional benefit from omega-3s.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults 18 to 65 with newly diagnosed celiac disease, who have not yet started a gluten-free diet, will be randomized to receive either 2.4 grams per day of omega-3 fatty acids or a placebo for three months while beginning a supervised gluten-free diet. The trial will measure markers of inflammation in the blood and assess intestinal healing. This is an interventional study conducted alongside standard dietary treatment to see if omega-3s offer additional benefit. The study is led by the University of Chile with collaboration from Clínica Universidad de los Andes and is based at the University of Chile Clinical Hospital in Santiago.
Why it matters
Potential benefit: If successful, omega-3 supplementation could enhance intestinal healing and reduce inflammation beyond diet alone.
How similar studies have gone: Earlier research in other inflammatory conditions suggests omega-3s can modulate inflammation, but results in celiac disease are not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 18 to 65 years, Newly diagnosed with celiac disease confirmed by serology and intestinal biopsy, Not yet started gluten-free diet (GFD), Willingness to adhere to a supervised gluten-free diet during the study, Able to provide informed consent Exclusion Criteria: * Previous or current adherence to a gluten-free diet, Use of n-3 PUFA supplements or other dietary supplements influencing inflammation within the last 3 months, Presence of other autoimmune, inflammatory, or gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis), Pregnancy or breastfeeding, Severe chronic illnesses that may interfere with the study or outcomes (e.g., uncontrolled diabetes, cancer), Allergy or intolerance to fish oil or components of the supplement, Use of immunosuppressive or anti-inflammatory medication within the last 3 months
Where it's running
-
University of Chile Clinical Hospital
Santiago, Metropolitan Region, Chile Recruiting
Study contacts
- Study coordinator: Karla A Bascuñán, PhD
- Email: kbascunan@uchile.cl
- Phone: +56 2 9773232
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.