Very Low Calorie Liquid Diet for Pre op Patients

December 10, 2012 updated by: Silvia Leite Faria

Use of Very Low Calorie Liquid Diet in the Preoperative Phase of Bariatric Surgery

Despite the relative consensus on the benefits of pre-surgical weight loss, i.e., the reduction of comorbidities associated with surgical act, such as decreased visceral fat, liver volume, hemorrhage perioperative and surgical time, the characteristics of the diet to be employed in this period need to be defined more clearly. As there is no description of comparative studies on diet of normal consistency, using solids and liquids, there are doubts as to the real need for consistency liquid diet in preoperative bariatric surgery. The lack of robust evidence has made nutrition professionals adopt different procedures. There is still a belief that these patients are unable to lose weight in the preoperative period, the ongoing history of previous attempts without success.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil
        • Gastrocirurgia de Brasilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To be clinically severe obese; To be in preoperative phase of bariatric surgery.

Exclusion Criteria:

  • Pregnancy and minors under 18 and adults over 60 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liquid Diet Group
The group followed a very low calorie liquid diet for two weeks
Other: A very low calorie diet of two different consistencies
Liquid and normal consistency diet with a very low calorie diet will be given to patients pre-operatively in bariatric surgery
Active Comparator: Control Group
The group followed a very low calorie diet of normal consistency for two weeks.
Other: A very low calorie diet of two different consistencies
Liquid and normal consistency diet with a very low calorie diet will be given to patients pre-operatively in bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loss of body weight
Time Frame: 2 weeks
The patients were weighed at the start and after following a liquid diet for tow weeks they were weighed again.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total body, visceral and liver fat loss, resting metabolic rate and changes in blood and urinary parameters
Time Frame: 2 weeks
At the start, bioimpedance and indirect calorimetry exams, abdominal ultrasound scans, blood tests and urinary exams were made of the patients and after following a set diet for 2 weeks these measurements were taken again.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silvia Leite Faria

Collaborators

University of Brasilia
Gastrocirurgia, Brazil

Investigators

  • Principal Investigator: Silvia L Faria, MSc, Gastrocirurgia of Brasilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Estimate)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 10, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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