Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 3:53 PM
Study NCT ID:
NCT06405906
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D042882', 'term': 'Gallstones'}, {'id': 'D003085', 'term': 'Colic'}, {'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D017562', 'term': 'Postcholecystectomy Syndrome'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018752', 'term': 'Diet, Fat-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 242}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-04', 'studyFirstSubmitDate': '2024-05-04', 'studyFirstSubmitQcDate': '2024-05-04', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in health-related quality of life as measured by the GIQLI score (RADIGAL1/2)', 'timeFrame': 'Baseline, 3-month follow-up', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Patient adherence to the suggested diet (RADIGAL1/2)', 'timeFrame': 'Baseline, 3-month follow-up', 'description': '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.'}, {'measure': 'Unplanned Emergency Department (ED) visit or hospital admission (RADIGAL1/2)', 'timeFrame': 'Baseline, 3-month follow-up', 'description': 'Patients will be asked about emergency department visits or hospital admissions related to the gallstone disease.'}, {'measure': 'Symptom Recurrence (RADIGAL1/2)', 'timeFrame': 'Baseline, 3-month follow-up', 'description': 'Patients will be asked if they experienced postprandial abdominal pain, nausea, vomiting, or dyspepsia.'}, {'measure': 'Unplanned or elective cholecystectomy (RADIGAL1)', 'timeFrame': 'Baseline, 3-month follow-up', 'description': 'Patients who treated non-operatively will be asked if they underwent unplanned or elective surgery.'}, {'measure': 'Time of Diet Discontinuation (weeks or months) (RADIGAL1/2)', 'timeFrame': 'Baseline, 3-month follow-up', 'description': 'Patients will be asked how long after the first visit or discharge they stopped following the given diet.'}, {'measure': 'Reason for discontinuing diet (RADIGAL1/2)', 'timeFrame': 'Baseline, 3-month follow-up', 'description': 'Patients will be asked if the reason for discontinuing the given diet is one of the following: Improvement or absence of symptoms\n\n* No improvement of symptoms\n* Worsening of symptoms\n* Personal reasons\n* Inability to adhere to the diet for such a long period\n* Hospital admission\n* Advice from another surgeon.'}, {'measure': 'Food categories chosen when not following diet (RADIGAL1/2)', 'timeFrame': 'Baseline, 3-month follow-up', 'description': 'Patients will be asked which of the following food categories they chose to consume when they stopped following the suggested diet:\n\n* Fatty and red meats\n* Fried and butter products\n* Sugar, soft drinks, sweets, and processed snacks\n* Fatty dairy products\n* High salt and cold cuts'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gallstone disease', 'cholecystitis', 'cholecystectomy', 'gallbladder diet'], 'conditions': ['Gallstone Disease', 'Gallstone; Colic', 'Gallstone; Cholecystitis, Acute', 'Cholelithiases', 'Postcholecystectomy Syndrome', 'Dietary Habits']}, 'descriptionModule': {'briefSummary': '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:\n\n• 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)?\n\nA 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).\n\nParticipants presenting with biliary colic or acute cholecystitis (RADIGAL-1) or undergoing cholecystectomy for gallstones (RADIGAL-2) will:\n\n* be randomly assigned to recommending either a fat-free or a balanced WHO diet .\n* be contacted via phone call to complete the GIQLI questionnaire and document overall adherence to the diets and secondary outcome events.\n\nThis trial examines the impact of diet on adverse events in gallstone disease, representing the first randomized study to focus on this aspect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (RADIGAL1):\n\n* 18 years old or older\n* presenting with biliary colic in the ED or outpatient clinic, with the surgical team deciding to proceed with non-operative treatment (Group 1)\n* presenting with acute calculous cholecystitis in the ED, with the surgical team deciding to proceed with non-operative management (Group 2)\n\nExclusion Criteria (RADIGAL1):\n\n* history of gastrointestinal disease which might affect diet, e.g., inflammatory bowel disease, irritable bowel syndrome, short bowel syndrome\n* inability to provide informed consent\n* unwillingness to adhere to the recommended diet\n* food allergies or intolerances that would prevent following the diet\n* dietary habits (e.g., vegetarians, vegans) that preclude adherence to the recommended diet\n* gallstone related cholangitis without biliary colic or cholecystitis\n* complications from acute pancreatitis, such as pseudocysts, walled off necrosis, among others\n\nInclusion Criteria (RADIGAL2):\n\n* 18 years old or older\n* undergoing uncomplicated cholecystectomy (open or laparoscopic without bile duct exploration) due to a history of biliary colic (Group 1)\n* undergoing uncomplicated cholecystectomy (open or laparoscopic without bile duct exploration) due to acute cholecystitis (Group 2)\n\nExclusion Criteria (RADIGAL2):\n\n* history of gastrointestinal disease which might affect diet, e.g., inflammatory bowel disease, irritable bowel syndrome, short bowel syndrome\n* inability to provide informed consent\n* unwillingness to adhere to the recommended diet\n* food allergies or intolerances that would prevent following the diet - dietary habits (e.g., vegetarians, vegans) that preclude adherence to the recommended diet\n* gallstone related cholangitis without biliary colic or cholecystitis\n* complications from acute pancreatitis, such as pseudocysts, walled off necrosis, among others\n* choledocholithiasis\n* complicated cholecystectomy\n* patients undergoing subtotal cholecystectomy\n* whether primary operation differs from cholecystectomy (e.g., colectomy)\n* patients having treated with percutaneous cholecystostomy'}, 'identificationModule': {'nctId': 'NCT06405906', 'acronym': 'RADIGAL', 'briefTitle': 'A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Crete'}, 'officialTitle': 'Rationale Diet for Gallstone Disease (RADIGAL Trial): A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease', 'orgStudyIdInfo': {'id': '5414/27-03-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biliary Colic Group - Non-operative Treatment - RADIGAL1', 'description': '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.', 'interventionNames': ['Other: Fat-free diet', 'Other: Balanced WHO diet']}, {'type': 'EXPERIMENTAL', 'label': 'Cholecystitis Group - Non-operative Treatment - RADIGAL1', 'description': '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.', 'interventionNames': ['Other: Fat-free diet', 'Other: Balanced WHO diet']}, {'type': 'EXPERIMENTAL', 'label': 'Biliary Colic Group - Cholecystectomy - RADIGAL2', 'description': 'Patients undergoing cholecystectomy due to biliary colic will be randomly assigned to receive fat-free diet or balanced diet for 3 months.', 'interventionNames': ['Other: Fat-free diet', 'Other: Balanced WHO diet']}, {'type': 'EXPERIMENTAL', 'label': 'Cholecystitis Group - Cholecystectomy - RADIGAL2', 'description': 'Patients undergoing cholecystectomy due to acute cholecystitis will be randomly assigned to receive fat-free diet or balanced diet for 3 months.', 'interventionNames': ['Other: Fat-free diet', 'Other: Balanced WHO diet']}], 'interventions': [{'name': 'Fat-free diet', 'type': 'OTHER', 'description': 'The low-fat diet will consist of instructions to avoid fatty foods.', 'armGroupLabels': ['Biliary Colic Group - Cholecystectomy - RADIGAL2', 'Biliary Colic Group - Non-operative Treatment - RADIGAL1', 'Cholecystitis Group - Cholecystectomy - RADIGAL2', 'Cholecystitis Group - Non-operative Treatment - RADIGAL1']}, {'name': 'Balanced WHO diet', 'type': 'OTHER', 'description': 'The balanced WHO diet will adhere to the recommendations of the World Health Organization (WHO) and the Dietary Guidelines for Americans 2020-2025', 'armGroupLabels': ['Biliary Colic Group - Cholecystectomy - RADIGAL2', 'Biliary Colic Group - Non-operative Treatment - RADIGAL1', 'Cholecystitis Group - Cholecystectomy - RADIGAL2', 'Cholecystitis Group - Non-operative Treatment - RADIGAL1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71110', 'city': 'Heraklion', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Konstantinos Lasithiotakis', 'role': 'CONTACT', 'email': 'k.lasithiotakis@uoc.gr', 'phone': '00302810392677'}], 'facility': 'Department of Surgery, University Hospital of Heraklion', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}], 'centralContacts': [{'name': 'Konstantinos Lasithiotakis, MD, PhD', 'role': 'CONTACT', 'email': 'k.lasithiotakis@uoc.gr', 'phone': '00302810392677'}], 'overallOfficials': [{'name': 'Konstantinos Lasithiotakis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, University Hospital of Heraklion'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Crete', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Konstantinos Lasithiotakis', 'investigatorAffiliation': 'University Hospital of Crete'}}}}