- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01748682
Very Low Calorie Liquid Diet for Pre op Patients
December 10, 2012 updated by: Silvia Leite Faria
Use of Very Low Calorie Liquid Diet in the Preoperative Phase of Bariatric Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Distrito Federal
-
Brasilia, Distrito Federal, Brazil
- Gastrocirurgia de Brasilia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liquid Diet Group
The group followed a very low calorie liquid diet for two weeks
|
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.
|
Liquid and normal consistency diet with a very low calorie diet will be given to patients pre-operatively in bariatric surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Silvia L Faria, MSc, Gastrocirurgia of Brasilia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
December 7, 2012
First Submitted That Met QC Criteria
December 10, 2012
First Posted (Estimate)
December 12, 2012
Study Record Updates
Last Update Posted (Estimate)
December 12, 2012
Last Update Submitted That Met QC Criteria
December 10, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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