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

Dietary Habits Clinical Trial

— RADIGAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06405906
• Other study ID #: 5414/27-03-2024
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: University Hospital of Crete
• Contact: Konstantinos Lasithiotakis, MD, PhD
• Phone: 00302810392677
• Email: k.lasithiotakis[@]uoc.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute
• Cholecystolithiasis
• Cholelithiases
• Cholelithiasis
• Dietary Habits
• Gallstone Disease
• Gallstone; Cholecystitis, Acute
• Gallstone; Colic
• Gallstones
• Postcholecystectomy Syndrome

Intervention

Other:
• Fat-free diet
The low-fat diet will consist of instructions to avoid fatty foods.
• Balanced WHO diet
The balanced WHO diet will adhere to the recommendations of the World Health Organization (WHO) and the Dietary Guidelines for Americans 2020-2025

Locations

Country	Name	City	State
Greece	Department of Surgery, University Hospital of Heraklion	Heraklion

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in health-related quality of life as measured by the GIQLI score (RADIGAL1/2)	The GIQLI questionnaire contains 36 questions on gastrointestinal symptoms (19 items), physical status (7 items), emotional status (5 items), and social function status (5 items). Patient responses are recorded as 'all the time, most of the time, some of the time, a little of the time, or never'. The most favorable option is scored as 4 points, whereas the least favorable option receives 0 points.	Baseline, 3-month follow-up
Secondary	Patient adherence to the suggested diet (RADIGAL1/2)	Patients will be queried if they followed the given diet daily, more than half the days of the month, less than half the days of the month or not at all.	Baseline, 3-month follow-up
Secondary	Unplanned Emergency Department (ED) visit or hospital admission (RADIGAL1/2)	Patients will be asked about emergency department visits or hospital admissions related to the gallstone disease.	Baseline, 3-month follow-up
Secondary	Symptom Recurrence (RADIGAL1/2)	Patients will be asked if they experienced postprandial abdominal pain, nausea, vomiting, or dyspepsia.	Baseline, 3-month follow-up
Secondary	Unplanned or elective cholecystectomy (RADIGAL1)	Patients who treated non-operatively will be asked if they underwent unplanned or elective surgery.	Baseline, 3-month follow-up
Secondary	Time of Diet Discontinuation (weeks or months) (RADIGAL1/2)	Patients will be asked how long after the first visit or discharge they stopped following the given diet.	Baseline, 3-month follow-up
Secondary	Reason for discontinuing diet (RADIGAL1/2)	Patients will be asked if the reason for discontinuing the given diet is one of the following: Improvement or absence of symptoms; No improvement of symptoms; Worsening of symptoms; Personal reasons; Inability to adhere to the diet for such a long period; Hospital admission; Advice from another surgeon.	Baseline, 3-month follow-up
Secondary	Food categories chosen when not following diet (RADIGAL1/2)	Patients will be asked which of the following food categories they chose to consume when they stopped following the suggested diet: Fatty and red meats; Fried and butter products; Sugar, soft drinks, sweets, and processed snacks; Fatty dairy products; High salt and cold cuts	Baseline, 3-month follow-up