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Very Low Calorie Liquid Diet for Pre op Patients

NCT ID: NCT01748682

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Morbid Obesity Steatosis

Keywords

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Very low calorie diet liquid diet visceral fat liver fat.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liquid Diet Group

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

Group Type EXPERIMENTAL

A very low calorie diet of two different consistencies

Intervention Type OTHER

Liquid and normal consistency diet with a very low calorie diet will be given to patients pre-operatively in bariatric surgery

Control Group

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

Group Type ACTIVE_COMPARATOR

A very low calorie diet of two different consistencies

Intervention Type OTHER

Liquid and normal consistency diet with a very low calorie diet will be given to patients pre-operatively in bariatric surgery

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gastrocirurgia, Brazil

OTHER

Sponsor Role collaborator

University of Brasilia

OTHER

Sponsor Role collaborator

Silvia Leite Faria

OTHER

Sponsor Role lead

Responsible Party

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Silvia Leite Faria

Master in Human Nutrition

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Silvia L Faria, MSc

Role: PRINCIPAL_INVESTIGATOR

Gastrocirurgia of Brasilia

Locations

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Gastrocirurgia de Brasilia

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id