Very Low Calorie Liquid Diet for Pre op Patients

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748682
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: December 10, 2012
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2012
• Source: Gastrocirurgia, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Steatosis

Intervention

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

Locations

Country	Name	City	State
Brazil	Gastrocirurgia de Brasilia	Brasilia	Distrito Federal

Sponsors (3)

Lead Sponsor	Collaborator
Silvia Leite Faria	Gastrocirurgia, Brazil, University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of body weight	The patients were weighed at the start and after following a liquid diet for tow weeks they were weighed again.	2 weeks	No
Secondary	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.	2 weeks	No