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Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities

NCT04583683 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2021-05-25

No results posted yet for this study

Summary

It is a prospective randomized trial on 218 subjects, 109 for each arms. The purpose of this trial is to compare very low calorie diet and metabolic surgery induced weight loss and its maintenance.

Conditions

  • Obesity, Morbid
  • Obesity
  • Diet, Healthy
  • Bariatric Surgery Candidate

Interventions

BEHAVIORAL

Very low calorie diet with Fortimel (Nutricia) supplementation

Patients will undergo a very low calorie diet

PROCEDURE

Metabolic Surgery

Patients will undergo metabolic surgery

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2020-12-28
Completion
2022-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT04583683 on ClinicalTrials.gov