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Very Low Calorie Liquid Diet for Pre op Patients

Primary Purpose

Morbid Obesity, Steatosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
A very low calorie diet of two different consistencies
Sponsored by
Silvia Leite Faria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Very low calorie diet, liquid diet, visceral fat, liver fat.

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Gastrocirurgia de Brasilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liquid Diet Group

Control Group

Arm Description

The group followed a very low calorie liquid diet for two weeks

The group followed a very low calorie diet of normal consistency for two weeks.

Outcomes

Primary Outcome Measures

Loss of body weight
The patients were weighed at the start and after following a liquid diet for tow weeks they were weighed again.

Secondary Outcome Measures

Total body, visceral and liver fat loss, resting metabolic rate and changes in blood and urinary parameters
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.

Full Information

First Posted
December 7, 2012
Last Updated
December 10, 2012
Sponsor
Silvia Leite Faria
Collaborators
Gastrocirurgia, Brazil, University of Brasilia
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1. Study Identification

Unique Protocol Identification Number
NCT01748682
Brief Title
Very Low Calorie Liquid Diet for Pre op Patients
Official Title
Use of Very Low Calorie Liquid Diet in the Preoperative Phase of Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Silvia Leite Faria
Collaborators
Gastrocirurgia, Brazil, University of Brasilia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Steatosis
Keywords
Very low calorie diet, liquid diet, visceral fat, liver fat.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liquid Diet Group
Arm Type
Experimental
Arm Description
The group followed a very low calorie liquid diet for two weeks
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The group followed a very low calorie diet of normal consistency for two weeks.
Intervention Type
Other
Intervention Name(s)
A very low calorie diet of two different consistencies
Intervention Description
Liquid and normal consistency diet with a very low calorie diet will be given to patients pre-operatively in bariatric surgery
Primary Outcome Measure Information:
Title
Loss of body weight
Description
The patients were weighed at the start and after following a liquid diet for tow weeks they were weighed again.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Total body, visceral and liver fat loss, resting metabolic rate and changes in blood and urinary parameters
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia L Faria, MSc
Organizational Affiliation
Gastrocirurgia of Brasilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrocirurgia de Brasilia
City
Brasilia
State/Province
Distrito Federal
Country
Brazil

12. IPD Sharing Statement

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Very Low Calorie Liquid Diet for Pre op Patients

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