Functional fatty acid-based dietary therapy as a new strategy for small gallstone expulsion: study protocol for a prospective, single-center, double-blind, randomized controlled trial

Fuente: PubMed "olive oil"
Front Nutr. 2026 Jul 3;13:1859377. doi: 10.3389/fnut.2026.1859377. eCollection 2026.ABSTRACTBACKGROUND: Gallstone disease is a major global health concern with a steadily increasing prevalence, affecting approximately 7% of the global population and imposing substantial health and economic burdens. Globally, gallstone disease accounts for 10-15% of all gastrointestinal hospital admissions, with annual direct medical costs exceeding $6 billion in the United States and ¥20 billion in China, primarily driven by cholecystectomy and post-surgical complications. According to clinical observations, oral administration of olive oil may facilitate the expulsion of small gallstones; however, high-quality evidence supporting this dietary therapy remains limited. In our preliminary study, a 6-day regimen of orally administered functional fatty acids effectively promoted the elimination of small gallstones.OBJECTIVE: This study aims to evaluate the efficacy and safety of oral functional fatty acid supplementation for facilitating the expulsion of small gallbladder stones, and to assess its potential as a noninvasive therapeutic option. The primary endpoint is the complete expulsion rate of small gallbladder stones at day 3 post-intervention, confirmed by two independent blinded ultrasound technologists. The complete expulsion rate at day 6 post-intervention is designated as a key secondary endpoint.METHODS: This prospective, single-center, double-blind, randomized controlled trial will enroll 100 adult patients with ultrasonographically confirmed small gallstones (maximum diameter <2 mm) and no prior treatment history. Participants will be randomly assigned at a 1:1 ratio to either the intervention group (n = 50), which will receive 50 mL of functional fatty acids daily on an empty stomach for 6 consecutive days, or the control group (n = 50), which will receive placebo for the first 3 days followed by the same dose of functional fatty acids for the subsequent 3 days. Abdominal ultrasound examinations will be performed on days 3 and 6 post-intervention to assess gallstone expulsion. Adverse events, including nausea, vomiting, abdominal pain, diarrhea, and signs of biliary obstruction, will be closely monitored throughout the study period.DISCUSSION: If proven effective, this intervention could provide a noninvasive alternative to surgery for patients with small gallstones, inform clinical practice, and help reduce the healthcare burden associated with gallstone disease.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT06699030.PMID:42490892 | PMC:PMC13375476 | DOI:10.3389/fnut.2026.1859377