Very Low Calorie Liquid Diet for Pre op Patients

NCT01748682 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Steatosis

Keywords

Very low calorie diet; liquid diet; visceral fat; liver fat.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Total body, visceral and liver fat loss, resting metabolic rate and changes in blood and urinary parameters

  2 weeks

Study Arms (2)

Liquid Diet Group

EXPERIMENTAL

The group followed a very low calorie liquid diet for two weeks

Other: A very low calorie diet of two different consistencies

Control Group

ACTIVE COMPARATOR

The group followed a very low calorie diet of normal consistency for two weeks.

Other: A very low calorie diet of two different consistencies

Interventions

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

Control Group; Liquid Diet Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be clinically severe obese; To be in preoperative phase of bariatric surgery.

You may not qualify if:

• Pregnancy and minors under 18 and adults over 60 years of age.

Sponsors & Collaborators

• Silvia Leite Faria: lead
• Gastrocirurgia, Brazil: collaborator
• University of Brasilia: collaborator

Study Sites (1)

Gastrocirurgia de Brasilia

Brasília, Federal District, Brazil

Location

MeSH Terms

Conditions

Obesity, Morbid; Fatty Liver

Condition Hierarchy (Ancestors)

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

Study Officials

• Silvia L Faria, MSc

  Gastrocirurgia of Brasilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master in Human Nutrition

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 12, 2012
• Study Start: January 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

BR (1)