A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease

Launched by UNIVERSITY HOSPITAL OF CRETE · May 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different diets—specifically a fat-free diet versus a balanced diet recommended by the World Health Organization (WHO)—affect the quality of life for patients with gallstone disease. The goal is to find out if one diet is better than the other for people experiencing symptoms from gallstones or those who have had surgery to remove their gallbladder. Participants will answer questions about their health and eating habits before and after following one of the two diets for three months.

To be eligible for this trial, participants must be 18 years or older and either have symptoms of gallstones or be scheduled for gallbladder surgery. Those with certain gastrointestinal diseases, food allergies, or specific dietary restrictions may not be able to participate. If you join, you'll be randomly assigned to one of the two diets and will complete a questionnaire by phone to share how you're feeling and how well you're sticking to the diet. This study is the first of its kind to explore how diet influences health outcomes in gallstone disease, making it an important step in understanding the role of nutrition in managing this condition.

Gender

ALL

Eligibility 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