Comparing fat-free and balanced diets for gallstone disease management
Rationale Diet for Gallstone Disease (RADIGAL Trial): A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease
This study is testing whether a fat-free diet or a balanced diet can help improve the quality of life for people with gallstone disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 242 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of Crete Academic / other |
| Locations | 1 site (Heraklion) |
| Trial ID | NCT06405906 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the impact of a fat-free diet versus a balanced WHO diet on the quality of life in patients with gallstone disease. It focuses on symptomatic patients presenting with biliary colic or acute cholecystitis, assessing patient-reported outcomes through a validated questionnaire. The study will analyze differences in quality of life scores at three months and monitor adherence to the diet and occurrence of disease-related symptoms. The trial is divided into two groups based on treatment approach: non-operative management and post-cholecystectomy care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with symptomatic gallstone disease, specifically those experiencing biliary colic or acute cholecystitis.
Not a fit: Patients with gastrointestinal diseases that affect diet, food allergies, or those unwilling to adhere to the recommended diets may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for dietary recommendations that improve quality of life for patients with gallstone disease.
How similar studies have performed: While dietary interventions in gallstone disease have been explored, this specific comparison of fat-free versus balanced diets is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (RADIGAL1): * 18 years old or older * presenting with biliary colic in the ED or outpatient clinic, with the surgical team deciding to proceed with non-operative treatment (Group 1) * presenting with acute calculous cholecystitis in the ED, with the surgical team deciding to proceed with non-operative management (Group 2) Exclusion Criteria (RADIGAL1): * history of gastrointestinal disease which might affect diet, e.g., inflammatory bowel disease, irritable bowel syndrome, short bowel syndrome * inability to provide informed consent * unwillingness to adhere to the recommended diet * food allergies or intolerances that would prevent following the diet * dietary habits (e.g., vegetarians, vegans) that preclude adherence to the recommended diet * gallstone related cholangitis without biliary colic or cholecystitis * complications from acute pancreatitis, such as pseudocysts, walled off necrosis, among others Inclusion Criteria (RADIGAL2): * 18 years old or older * undergoing uncomplicated cholecystectomy (open or laparoscopic without bile duct exploration) due to a history of biliary colic (Group 1) * undergoing uncomplicated cholecystectomy (open or laparoscopic without bile duct exploration) due to acute cholecystitis (Group 2) Exclusion Criteria (RADIGAL2): * history of gastrointestinal disease which might affect diet, e.g., inflammatory bowel disease, irritable bowel syndrome, short bowel syndrome * inability to provide informed consent * unwillingness to adhere to the recommended diet * food allergies or intolerances that would prevent following the diet - dietary habits (e.g., vegetarians, vegans) that preclude adherence to the recommended diet * gallstone related cholangitis without biliary colic or cholecystitis * complications from acute pancreatitis, such as pseudocysts, walled off necrosis, among others * choledocholithiasis * complicated cholecystectomy * patients undergoing subtotal cholecystectomy * whether primary operation differs from cholecystectomy (e.g., colectomy) * patients having treated with percutaneous cholecystostomy
Where this trial is running
Heraklion
- Department of Surgery, University Hospital of Heraklion — Heraklion, Greece (Recruiting)
Study contacts
- Principal investigator: Konstantinos Lasithiotakis, MD, PhD — Department of Surgery, University Hospital of Heraklion
- Study coordinator: Konstantinos Lasithiotakis, MD, PhD
- Email: k.lasithiotakis@uoc.gr
- Phone: 00302810392677
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.