An interventional study of Fat-free diet and Balanced WHO diet in Gallstone Disease, Gallstone; Colic and Gallstone; Cholecystitis, Acute, sponsored by University Hospital of Crete. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by University Hospital of Crete · Not applicable, Interventional, and Screening
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:
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:
This trial examines the impact of diet on adverse events in gallstone disease, representing the first randomized study to focus on this aspect.
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's planned enrollment of 242 is above the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →University Hospital of Crete is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Compared within Gallstones, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cholelithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria (RADIGAL1):
Exclusion Criteria (RADIGAL1):
Inclusion Criteria (RADIGAL2):
Exclusion Criteria (RADIGAL2):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
The low-fat diet will consist of instructions to avoid fatty foods.
The balanced WHO diet will adhere to the recommendations of the World Health Organization (WHO) and the Dietary Guidelines for Americans 2020-2025
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.
Time frame: Baseline, 3-month follow-up
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.
Time frame: Baseline, 3-month follow-up
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.
Time frame: Baseline, 3-month follow-up
Symptom Recurrence (RADIGAL1/2)
Patients will be asked if they experienced postprandial abdominal pain, nausea, vomiting, or dyspepsia.
Time frame: Baseline, 3-month follow-up
Unplanned or elective cholecystectomy (RADIGAL1)
Patients who treated non-operatively will be asked if they underwent unplanned or elective surgery.
Time frame: Baseline, 3-month follow-up
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.
Time frame: Baseline, 3-month follow-up
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.
Time frame: Baseline, 3-month follow-up
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
Time frame: Baseline, 3-month follow-up
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Dec 2025, 20 months after the start.
Of 58 non-industry interventional studies with no phase under Gallstones, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 20 months is close to that.
Counting every sponsor, half of 58 studies reached it within 20 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital of Crete