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Very Low Calorie Liquid Diet for Pre op Patients

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ClinicalTrials.gov Identifier: NCT01748682
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : December 12, 2012
Sponsor:
Collaborators:
Gastrocirurgia, Brazil
University of Brasilia
Information provided by (Responsible Party):
Silvia Leite Faria, Gastrocirurgia, Brazil

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Steatosis Other: A very low calorie diet of two different consistencies Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Very Low Calorie Liquid Diet in the Preoperative Phase of Bariatric Surgery
Study Start Date : January 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748682


Locations
Brazil
Gastrocirurgia de Brasilia
Brasilia, Distrito Federal, Brazil
Sponsors and Collaborators
Silvia Leite Faria
Gastrocirurgia, Brazil
University of Brasilia
Investigators
Principal Investigator: Silvia L Faria, MSc Gastrocirurgia of Brasilia

Responsible Party: Silvia Leite Faria, Master in Human Nutrition, Gastrocirurgia, Brazil
ClinicalTrials.gov Identifier: NCT01748682     History of Changes
Other Study ID Numbers: 001
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Silvia Leite Faria, Gastrocirurgia, Brazil:
Very low calorie diet
liquid diet
visceral fat
liver fat.

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms