Very Low Calorie Liquid Diet for Pre op Patients

Not Applicable

Completed

• Conditions: Morbid Obesity; Steatosis
• Interventions: Other: A very low calorie diet of two different consistencies

• Registration Number: NCT01748682
• Lead Sponsor: Silvia Leite Faria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-12
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-10
• Last Update Submitted: 2012-12-10
• Study First Posted: 2012-12-12
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	A very low calorie diet of two different consistencies	The group followed a very low calorie diet of normal consistency for two weeks.
Liquid Diet Group	A very low calorie diet of two different consistencies	The group followed a very low calorie liquid diet for two weeks

Primary Outcome Measures

Name	Time	Method
Loss of body weight	2 weeks	The patients were weighed at the start and after following a liquid diet for tow weeks they were weighed again.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gastrocirurgia de Brasilia; 🇧🇷 Brasilia, Distrito Federal, Brazil