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

NCT06405906 | Recruiting

• 1 other identifier: 5414/27-03-2024
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gallstone Disease; Gallstone; Colic; Gallstone; Cholecystitis, Acute; Cholelithiases; Postcholecystectomy Syndrome; Dietary Habits

Keywords

gallstone disease; cholecystitis; cholecystectomy; gallbladder diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Patient adherence to the suggested diet (RADIGAL1/2)

  Baseline, 3-month follow-up

• Unplanned Emergency Department (ED) visit or hospital admission (RADIGAL1/2)

  Baseline, 3-month follow-up

• Symptom Recurrence (RADIGAL1/2)

  Baseline, 3-month follow-up

• Unplanned or elective cholecystectomy (RADIGAL1)

  Baseline, 3-month follow-up

• Time of Diet Discontinuation (weeks or months) (RADIGAL1/2)

  Baseline, 3-month follow-up

Study Arms (4)

Biliary Colic Group - Non-operative Treatment - RADIGAL1

EXPERIMENTAL

Patients presenting with biliary colic and treated non-operatively will be randomly assigned to receive fat-free diet or balanced WHO diet for 3 months.

Other: Fat-free diet; Other: Balanced WHO diet

Cholecystitis Group - Non-operative Treatment - RADIGAL1

EXPERIMENTAL

Patients presenting with acute cholecystitis and treated non-operatively will be randomly assigned to receive fat-free diet or balanced WHO diet for 3 months.

Other: Fat-free diet; Other: Balanced WHO diet

Biliary Colic Group - Cholecystectomy - RADIGAL2

EXPERIMENTAL

Patients undergoing cholecystectomy due to biliary colic will be randomly assigned to receive fat-free diet or balanced diet for 3 months.

Other: Fat-free diet; Other: Balanced WHO diet

Cholecystitis Group - Cholecystectomy - RADIGAL2

EXPERIMENTAL

Patients undergoing cholecystectomy due to acute cholecystitis will be randomly assigned to receive fat-free diet or balanced diet for 3 months.

Other: Fat-free diet; Other: Balanced WHO diet

Interventions

Fat-free diet OTHER

The low-fat diet will consist of instructions to avoid fatty foods.

Biliary Colic Group - Cholecystectomy - RADIGAL2; Biliary Colic Group - Non-operative Treatment - RADIGAL1; Cholecystitis Group - Cholecystectomy - RADIGAL2; Cholecystitis Group - Non-operative Treatment - RADIGAL1

Balanced WHO diet OTHER

The balanced WHO diet will adhere to the recommendations of the World Health Organization (WHO) and the Dietary Guidelines for Americans 2020-2025

Biliary Colic Group - Cholecystectomy - RADIGAL2; Biliary Colic Group - Non-operative Treatment - RADIGAL1; Cholecystitis Group - Cholecystectomy - RADIGAL2; Cholecystitis Group - Non-operative Treatment - RADIGAL1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• University Hospital of Crete: lead

Study Sites (1)

Department of Surgery, University Hospital of Heraklion

Heraklion, 71110, Greece

RECRUITING

MeSH Terms

Conditions

Cholelithiasis; Gallstones; Colic; Cholecystitis; Postcholecystectomy Syndrome; Feeding Behavior

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Konstantinos Lasithiotakis, MD, PhD

  Department of Surgery, University Hospital of Heraklion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantinos Lasithiotakis, MD, PhD

CONTACT

00302810392677; k.lasithiotakis@uoc.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 9, 2024
• Study Start: March 27, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)