UnknownNot Applicable

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

Greece242 participantsStarted 2024-03-27

Plain-language summary

The goal of this trial is to assess the effect on the quality of life (QoL) of recommending a fat-free diet versus a balanced WHO diet in symptomatic patients with gallstones and in patients undergoing cholecystectomy for gallstone disease. The main question it aims to answer is: • Is balanced WHO diet as good as low-fat diet in terms of patient reported outcomes when gallstone disease is managed non-operatively (RADIGAL-1) or cholecystectomy is performed (RADIGAL-2)? A validated QoL questionnaire (Gastrointestinal Quality of Life Index - GIQLI) will be administered both at baseline and during follow-up. Analysis of covariance with ordinary least squares estimation will be applied to estimate between-group differences in GIQLI scores at 3 months (primary endpoint). Patient adherence and the disease-related symptoms occurrence or hospitalizations will also be appraised (secondary endpoint). Participants presenting with biliary colic or acute cholecystitis (RADIGAL-1) or undergoing cholecystectomy for gallstones (RADIGAL-2) will: * be randomly assigned to recommending either a fat-free or a balanced WHO diet . * be contacted via phone call to complete the GIQLI questionnaire and document overall adherence to the diets and secondary outcome events. This trial examines the impact of diet on adverse events in gallstone disease, representing the first randomized study to focus on this aspect.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * unwilling…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in health-related quality of life as measured by the GIQLI score (RADIGAL1/2)

Timeframe: Baseline, 3-month follow-up

Trial details

NCT IDNCT06405906

SponsorUniversity Hospital of Crete

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

Contact for this trial

Konstantinos Lasithiotakis, MD, PhD

00302810392677 k.lasithiotakis@uoc.gr

View on ClinicalTrials.gov More Gallstone Disease trials