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OpenTrials
Completed

NCT Number: NCT01748682

Very Low Calorie Liquid Diet for Pre op Patients

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.

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Key information

Conditions

Morbid Obesity Body Weight Digestive System Diseases Fatty Liver Liver Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Steatosis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastrocirurgia de Brasilia

Brasília, Federal District, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A very low calorie diet of two different consistencies

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Silvia Leite Faria

Other

Collaborators

  • Gastrocirurgia, Brazil
  • University of Brasilia

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 12, 2012
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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