Gallstone DiseaseRADIGALNCT06405906
A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease
A study testing Fat-free diet and Balanced WHO diet in people with Gallstone Disease and Gallstone; Colic, run by University Hospital of Crete at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstone Disease, Gallstone; Colic, Gallstone; Cholecystitis, Acute
- What is being tested?
- Fat-free diet and Balanced WHO diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteGreece
- Study dates
- 27 Mar 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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)
Who cannot join
- 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
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- complications from acute pancreatitis, such as pseudocysts, walled off necrosis, among others
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Department of Surgery, University Hospital of Heraklion
Heraklion, 71110
Konstantinos Lasithiotakis, 00302810392677, k.lasithiotakis@uoc.gr
About this study
Official title: Rationale Diet for Gallstone Disease (RADIGAL Trial): A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease
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)?
Read more
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
- Being tested
- Fat-free diet, Balanced WHO diet
- Keywords
- gallstone disease, cholecystitis, cholecystectomy, gallbladder diet
- Medical subject headings
- Cholelithiasis, Gallstones, Colic, Cholecystitis, Postcholecystectomy Syndrome, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat-free dietOther
The low-fat diet will consist of instructions to avoid fatty foods.
Balanced WHO dietOther
The balanced WHO diet will adhere to the recommendations of the World Health Organization (WHO) and the Dietary Guidelines for Americans 2020-2025
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Fat-free diet; Other: Balanced WHO diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3-month follow-up
Secondary outcomes (7)
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.
Measured: 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.
Measured: Baseline, 3-month follow-up
Symptom Recurrence (RADIGAL1/2)
Patients will be asked if they experienced postprandial abdominal pain, nausea, vomiting, or dyspepsia.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start27 Mar 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallstone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Lasithiotakis, University Hospital of Crete
- Investigators
- Konstantinos Lasithiotakis, MD, PhD, Principal investigator, Department of Surgery, University Hospital of Heraklion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405906
- Sponsor's protocol ID
- 5414/27-03-2024
- Acronym
- RADIGAL
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationale Diet for Gallstone Disease (RADIGAL Trial): A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease
- ClinicalTrials.gov ID
- NCT06405906
- Acronym / sponsor ID
- RADIGAL / 5414/27-03-2024
- Conditions
- Gallstone Disease, Gallstone; Colic, Gallstone; Cholecystitis, Acute, Cholelithiases, Postcholecystectomy Syndrome, Dietary Habits
- Keywords
- gallstone disease, cholecystitis, cholecystectomy, gallbladder diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- University Hospital of CreteUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biliary Colic Group - Non-operative Treatment - RADIGAL1 | Experimental | Other: Fat-free diet, Other: Balanced WHO dietPatients presenting with biliary colic and treated non-operatively will be randomly assigned to receive fat-free diet or balanced WHO diet for 3 months. |
| Cholecystitis Group - Non-operative Treatment - RADIGAL1 | Experimental | Other: Fat-free diet, Other: Balanced WHO dietPatients presenting with acute cholecystitis and treated non-operatively will be randomly assigned to receive fat-free diet or balanced WHO diet for 3 months. |
| Biliary Colic Group - Cholecystectomy - RADIGAL2 | Experimental | Other: Fat-free diet, Other: Balanced WHO dietPatients undergoing cholecystectomy due to biliary colic will be randomly assigned to receive fat-free diet or balanced diet for 3 months. |
| Cholecystitis Group - Cholecystectomy - RADIGAL2 | Experimental | Other: Fat-free diet, Other: Balanced WHO dietPatients undergoing cholecystectomy due to acute cholecystitis will be randomly assigned to receive fat-free diet or balanced diet for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
- 18 years old or older
- undergoing uncomplicated cholecystectomy (open or laparoscopic without bile duct exploration) due to a history of biliary colic (Group 1)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fat-free dietThe low-fat diet will consist of instructions to avoid fatty foods. | Other | Biliary Colic Group - Cholecystectomy - RADIGAL2, Biliary Colic Group - Non-operative Treatment - RADIGAL1, Cholecystitis Group - Cholecystectomy - RADIGAL2, Cholecystitis Group - Non-operative Treatment - RADIGAL1 |
| Balanced WHO dietThe balanced WHO diet will adhere to the recommendations of the World Health Organization (WHO) and the Dietary Guidelines for Americans 2020-2025 | Other | Biliary Colic Group - Cholecystectomy - RADIGAL2, Biliary Colic Group - Non-operative Treatment - RADIGAL1, Cholecystitis Group - Cholecystectomy - RADIGAL2, Cholecystitis Group - Non-operative Treatment - RADIGAL1 |
Primary outcome
Change in health-related quality of life as measured by the GIQLI score (RADIGAL1/2)
Time frame: Baseline, 3-month follow-up
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.
7 secondary outcomes
Patient adherence to the suggested diet (RADIGAL1/2)
Time frame: Baseline, 3-month follow-up
Unplanned Emergency Department (ED) visit or hospital admission (RADIGAL1/2)
Time frame: Baseline, 3-month follow-up
Symptom Recurrence (RADIGAL1/2)
Time frame: Baseline, 3-month follow-up
Unplanned or elective cholecystectomy (RADIGAL1)
Time frame: Baseline, 3-month follow-up
Time of Diet Discontinuation (weeks or months) (RADIGAL1/2)
Time frame: Baseline, 3-month follow-up
Reason for discontinuing diet (RADIGAL1/2)
Time frame: Baseline, 3-month follow-up
Food categories chosen when not following diet (RADIGAL1/2)
Time frame: Baseline, 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Lasithiotakis, MD, PhD principal investigator
Department of Surgery, University Hospital of Heraklion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat-free diet and Balanced WHO diet in people with Gallstone Disease and Gallstone; Colic, run by University Hospital of Crete at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Lasithiotakis, MD, PhD (00302810392677, k.lasithiotakis@uoc.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related quality of life as measured by the GIQLI score (RADIGAL1/2) (time frame: Baseline, 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.