Body CompositionNCT06267677
Efficacy of Liquid Versus Powder Protein Supplementation to Optimize Protein Intake After Bariatric Surgery
A study testing High protein liquid formula in people with Body Composition and Obesity, run by Hospital Clinic of Barcelona.
Trial summary
The goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Body Composition, Obesity, Protein Supplementation
- What is being tested?
- High protein liquid formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2008to 6 Mar 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes between 18 and 65 years of age undergoing bariatric surgery in our center With the ability to understand the objectives and proposals of the study That they agree to participate in the study.
Who cannot join
- Patients who have had perioperative complications and who require an extended hospital stay Patients who after the intervention require some type of artificial nutritional support Patients who have undergone a surgical technique other than BPG.
About this study
Official title: Efficacy of a Specific Complete Formula on Nutritional Status and Coverage of Protein Requirements After Obesity Surgery Compared to the Traditional Progressive Diet: a Prospective Randomized Study
The goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. The main question it aims to answer is if the addition of a high-protein, volume-controlled nutritional supplement as a fundamental part of the diet during the first two months after surgery will preserve the patient's nutritional status and prevent the appearance of nutritional deficits and associated complications.
Participants will be evaluated at the beginning, at 1 month and at the end of the study (2m) and the following determinations will be made:
- Analytical determination
- Nitrogen balance by determining urea N2 in 24-hour urine
- Anthropometric determinations
- Body composition determined by impedanciometry
- Resting energy expenditure and nutrient oxidation measured by indirect calorimetry.
- Energy, protein and hydration intake.
- Gastrointestinal tolerance through self-registration of symptoms. Researchers will compare the effect of a complete hypocaloric liquid formula group with the usual progressive diet group to see if they achieve the protein intake goal established for patients after obesity surgery, preservation of nutritional status and lean mass during the rapid phase of weight loss and the gastrointestinal tolerance during the first two months after surgery.
- Conditions
- Body Composition, Obesity, Protein Supplementation, Bariatric Surgery Candidate, Weight Loss
- Being tested
- High protein liquid formula
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein liquid formulaDietary supplement
liquid and high amount of protein
| Study group | Role | What they receive |
|---|---|---|
| High protein liquid formula | Experimental | Patients allocated in the intervention group (n=15) received 4 high-protein shakes and the corresponding standard vitamin-mineral (VM) supplementation according to our post BS protocol, then progressed towards a diet that combines traditional foods with 2 hLF shakes per day and VM supplementation for 15 days. Over the following 15 days, patients continued to normalize their diet, including a single hLF shake per day and continued with VM supplementation. Receives: Dietary Supplement: High protein liquid formula |
| Standard care diet | No intervention | Patients in the control group (n=35) followed the traditional protocol after bariatric surgery (sCD-group) consisting of a progressive diet with traditional foods, recommendation of 23g/d of protein powder and standard vitamin-mineral supplementation during the first 2 weeks after the surgery. From then on and according to current dietary protocols, the recommendation for protein powder decreases from 23g to 15g up to the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
protein intake
Achieving the protein intake goal established for patients after obesity surgery.
Measured: 2 months
evaluate nutritional deficiencies
Nutritional status and the preservation of lean mass during the rapid phase of weight loss
Measured: 2 months
Tolerance
Gastrointestinal tolerance during the first two months after surgery.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start2 Jan 2008
- Primary completion18 Apr 2008
- Study completion6 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Violeta Moizé, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267677
- Sponsor's protocol ID
- 2007/3928
- Status last verified
- Dec 2007
- First submitted
- 13 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Specific Complete Formula on Nutritional Status and Coverage of Protein Requirements After Obesity Surgery Compared to the Traditional Progressive Diet: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06267677
- Acronym / sponsor ID
- 2007/3928
- Conditions
- Body Composition, Obesity, Protein Supplementation, Bariatric Surgery Candidate, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 2 Jan 2008 (actual)
- Primary completion
- 18 Apr 2008 (actual)
- Study completion
- 6 Mar 2009 (actual)
- First posted
- 20 Feb 2024 (actual)
- 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.
The goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. The main question it aims to answer is if the addition of a high-protein, volume-controlled nutritional supplement as a fundamental part of the diet during the first two months after surgery will preserve the patient's nutritional status and prevent the appearance of nutritional deficits and associated complications.
Participants will be evaluated at the beginning, at 1 month and at the end of the study (2m) and the following determinations will be made:
- Analytical determination
- Nitrogen balance by determining urea N2 in 24-hour urine
- Anthropometric determinations
- Body composition determined by impedanciometry
- Resting energy expenditure and nutrient oxidation measured by indirect calorimetry.
- Energy, protein and hydration intake.
- Gastrointestinal tolerance through self-registration of symptoms. Researchers will compare the effect of a complete hypocaloric liquid formula group with the usual progressive diet group to see if they achieve the protein intake goal established for patients after obesity surgery, preservation of nutritional status and lean mass during the rapid phase of weight loss and the gastrointestinal tolerance during the first two months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High protein liquid formula | Experimental | Dietary Supplement: High protein liquid formulaPatients allocated in the intervention group (n=15) received 4 high-protein shakes and the corresponding standard vitamin-mineral (VM) supplementation according to our post BS protocol, then progressed towards a diet that combines traditional foods with 2 hLF shakes per day and VM supplementation for 15 days. Over the following 15 days, patients continued to normalize their diet, including a single hLF shake per day and continued with VM supplementation. |
| Standard care diet | No intervention | –Patients in the control group (n=35) followed the traditional protocol after bariatric surgery (sCD-group) consisting of a progressive diet with traditional foods, recommendation of 23g/d of protein powder and standard vitamin-mineral supplementation during the first 2 weeks after the surgery. From then on and according to current dietary protocols, the recommendation for protein powder decreases from 23g to 15g up to the end of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both sexes between 18 and 65 years of age undergoing bariatric surgery in our center With the ability to understand the objectives and proposals of the study That they agree to participate in the study.
Key exclusion criteria (1 listed)
- Patients who have had perioperative complications and who require an extended hospital stay Patients who after the intervention require some type of artificial nutritional support Patients who have undergone a surgical technique other than BPG.
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 |
|---|---|---|
| High protein liquid formulaliquid and high amount of protein | Dietary supplement | High protein liquid formula |
Primary outcome
protein intake
Time frame: 2 months
Achieving the protein intake goal established for patients after obesity surgery.
evaluate nutritional deficiencies
Time frame: 2 months
Nutritional status and the preservation of lean mass during the rapid phase of weight loss
Tolerance
Time frame: 2 months
Gastrointestinal tolerance during the first two months after surgery.
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 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High protein liquid formula in people with Body Composition and Obesity, run by Hospital Clinic of Barcelona.
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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
protein intake (time frame: 2 months). The study lists 3 primary outcomes in all. 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 20 Feb 2024.