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

NCT06405906 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2024-05-09

No results posted yet for this study

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

Interventions

OTHER

Fat-free diet

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

OTHER

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

Sponsors & Collaborators

  • University Hospital of Crete

    lead OTHER

Principal Investigators

  • Konstantinos Lasithiotakis, MD, PhD · Department of Surgery, University Hospital of Heraklion

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06405906 on ClinicalTrials.gov