Morbid ObesityNCT01748682
Very Low Calorie Liquid Diet for Pre op Patients
A study testing A very low calorie diet of two different consistencies in people with Morbid Obesity and Steatosis, run by Silvia Leite Faria at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity, Steatosis
- What is being tested?
- A very low calorie diet of two different consistencies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be clinically severe obese; To be in preoperative phase of bariatric surgery.
Who cannot join
- Pregnancy and minors under 18 and adults over 60 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Morbid Obesity, Steatosis
- Being tested
- A very low calorie diet of two different consistencies
- Keywords
- Very low calorie diet, liquid diet, visceral fat, liver fat.
- Medical subject headings
- Obesity, Morbid, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A very low calorie diet of two different consistenciesOther
Liquid and normal consistency diet with a very low calorie diet will be given to patients pre-operatively in bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Liquid Diet Group | Experimental | The group followed a very low calorie liquid diet for two weeks Receives: 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. Receives: Other: A very low calorie diet of two different consistencies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of body weight
The patients were weighed at the start and after following a liquid diet for tow weeks they were weighed again.
Measured: 2 weeks
Secondary outcomes (1)
Total body, visceral and liver fat loss, resting metabolic rate and changes in blood and urinary parameters
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startJan 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silvia Leite Faria
- Sponsor type
- University, hospital or other
- Collaborators
- Gastrocirurgia, Brazil, University of Brasilia
- Responsible party
- Sponsor-investigator, Silvia Leite Faria, Gastrocirurgia, Brazil
- Investigators
- Silvia L Faria, MSc, Principal investigator, Gastrocirurgia of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748682
- Sponsor's protocol ID
- 001
- Status last verified
- Dec 2012
- First submitted
- 7 Dec 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Very Low Calorie Liquid Diet in the Preoperative Phase of Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01748682
- Acronym / sponsor ID
- 001
- Conditions
- Morbid Obesity, Steatosis
- Keywords
- Very low calorie diet, liquid diet, visceral fat, liver fat.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Silvia Leite FariaUniversity, hospital or other
- Collaborators
- Gastrocirurgia, Brazil, University of Brasilia
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid Diet Group | Experimental | Other: A very low calorie diet of two different consistenciesThe group followed a very low calorie liquid diet for two weeks |
| Control Group | Active comparator | Other: A very low calorie diet of two different consistenciesThe group followed a very low calorie diet of normal consistency for two weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be clinically severe obese; To be in preoperative phase of bariatric surgery.
Key exclusion criteria (1 listed)
- Pregnancy and minors under 18 and adults over 60 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A very low calorie diet of two different consistenciesLiquid and normal consistency diet with a very low calorie diet will be given to patients pre-operatively in bariatric surgery | Other | Control Group, Liquid Diet Group |
Primary outcome
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.
1 secondary outcome
Total body, visceral and liver fat loss, resting metabolic rate and changes in blood and urinary parameters
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia L Faria, MSc principal investigator
Gastrocirurgia of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A very low calorie diet of two different consistencies in people with Morbid Obesity and Steatosis, run by Silvia Leite Faria at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of body weight (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.