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Very Low Calorie Liquid Diet for Pre op Patients

This study has been completed.
Sponsor:
Collaborators:
Gastrocirurgia, Brazil
University of Brasilia
Information provided by (Responsible Party):
Silvia Leite Faria, Gastrocirurgia, Brazil
ClinicalTrials.gov Identifier:
NCT01748682
First received: December 7, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Morbid Obesity
Steatosis
 Other: A very low calorie diet of two different consistencies

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Very Low Calorie Liquid Diet in the Preoperative Phase of Bariatric Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gastrocirurgia, Brazil:

Primary Outcome Measures:
  • Loss of body weight [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 104
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Silvia Leite Faria, Master in Human Nutrition, Gastrocirurgia, Brazil
ClinicalTrials.gov Identifier: NCT01748682     History of Changes
Other Study ID Numbers: 001
Study First Received: December 7, 2012
Last Updated: December 10, 2012
Health Authority: Brazil: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 19, 2013