ObesityPROTISLEEVENCT02712086
Controlled Trial Evaluating the Efficacy of Protein Supplementation in the Short Term After Bariatric Surgery
A study testing protein supplementation in people with Obesity, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- protein supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2016to 30 Oct 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- surgical management of sleeve gastrectomy kind
Who cannot join
- food allergies
- Weight> 135 kg (maximum weight supported by the DXA)
- orthopedic prosthesis (hip, knee ...) that would make it impossible to interpret the measurement of DXA
- History of bariatric surgery: adjustable gastric banding, vertical banded gastrectomy ...
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Prospective Single-center Open Evaluating the Efficacy of Supplementation (Adapted to the Post-operative Period) Current Protein After Bariatric Surgery Like Sleeve Gastrectomy
The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.
Secondary objectives will assess protein intake, food safety, the effect of protein supplementation on body fat in the entire body and the metabolic rate and the impact on quality of life and post-operative joint pain.
Read the detailed description
The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.
Secondary objectives will assess protein intake, food safety, the effect of protein supplementation on body fat in the entire body and the metabolic rate and the impact on quality of life and post-operative joint pain.
There is still no study evaluating the protein supplementation adapted patients after sleeve gastrectomy on maintaining lean body mass.
- Conditions
- Obesity
- Being tested
- protein supplementation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein supplementationOther
Protein supplementation : Protein intake of 30 grams of protein in addition to the usual inputs (to the recommended amounts of 60 to 120 g per day), upon the resumption of oral intake until the fifth week after sleeve gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| usual dietary management | No intervention | Control group: usual dietary management Following the intervention, the stomach of patients underwent many changes |
| care of with usual dietary protein supplementation | Experimental | Intervention group: Usual dietary management with protein supplementation (30g) in addition to the usual inputs Receives: Other: protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lean mass (kg) will be assessed at the level of whole-body dual-energy X-ray absorptiometry (DXA)
Measured: up to 1 month
Secondary outcomes (5)
food diary
The actual protein intake will be assessed using a food diary over 5 weeks completed by the patient
Measured: 5 weeks after the hospital discharge
change rate IGF1, IGFBP3
change rate IGF1, IGFBP3 between hospitalization and 1 month of hospital discharge
Measured: up to 1 month
the quality of life
The evolution of the quality of life will be assessed through a specific scale, Baros score.
Measured: up to 1 month
the quality of life
The evolution of the quality of life will be assessed through a specific scale, Baros score.
Measured: up to 5 years
change rate IGF1, IGFBP3
change rate IGF1, IGFBP3 between hospitalization and 5 years follow up
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start19 Oct 2016
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David NOCCA, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712086
- Sponsor's protocol ID
- RECHMPL15_0173
- Other IDs
- UF 9590
- Acronym
- PROTISLEEVE
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Maimoun L, Aouinti S, Puech M, Lefebvre P, Deloze M, de Santa Barbara P, Cristol JP, Brabant S, Gautier T, Nedelcu M, Renard E, Picot MC, Mariano-Goulart D, Nocca D. Effect of Nutritional Deprivation after Sleeve Gastrectomy on Bone Mass, Periostin, Sclerostin and Semaphorin 4D: A Two-Year Longitudinal Study. Nutrients. 2023 Oct 10;15(20):4310. doi: 10.3390/nu15204310.
PubMed 37892386Maimoun L, Aouinti S, Puech M, Lefebvre P, Deloze M, de Santa Barbara P, Renard E, Christol JP, Myzia J, Picot MC, Mariano-Goulart D, Nocca D. Changes in Lean Tissue Mass, Fat Mass, Biological Parameters and Resting Energy Expenditure over 24 Months Following Sleeve Gastrectomy. Nutrients. 2023 Feb 27;15(5):1201. doi: 10.3390/nu15051201.
PubMed 36904198Maimoun L, Aouinti S, Puech M, Lefebvre P, Humbert L, Deloze M, de Santa Barbara P, Maimoun-Nande L, Boudousq V, Cristol JP, Renard E, Picot MC, Mariano-Goulart D, Nocca D. Modification of bone architecture following sleeve gastrectomy: a five-year follow-up. J Bone Miner Res. 2025 Feb 2;40(2):251-261. doi: 10.1093/jbmr/zjae202.
PubMed 39693376
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Prospective Single-center Open Evaluating the Efficacy of Supplementation (Adapted to the Post-operative Period) Current Protein After Bariatric Surgery Like Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02712086
- Acronym / sponsor ID
- PROTISLEEVE / RECHMPL15_0173
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Oct 2016 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 17 Mar 2016 (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.
The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.
Secondary objectives will assess protein intake, food safety, the effect of protein supplementation on body fat in the entire body and the metabolic rate and the impact on quality of life and post-operative joint pain.
Detailed description
The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.
Secondary objectives will assess protein intake, food safety, the effect of protein supplementation on body fat in the entire body and the metabolic rate and the impact on quality of life and post-operative joint pain.
There is still no study evaluating the protein supplementation adapted patients after sleeve gastrectomy on maintaining lean body mass.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual dietary management | No intervention | –Control group: usual dietary management Following the intervention, the stomach of patients underwent many changes |
| care of with usual dietary protein supplementation | Experimental | Other: protein supplementationIntervention group: Usual dietary management with protein supplementation (30g) in addition to the usual inputs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- surgical management of sleeve gastrectomy kind
Key exclusion criteria (4 listed)
- food allergies
- Weight> 135 kg (maximum weight supported by the DXA)
- orthopedic prosthesis (hip, knee ...) that would make it impossible to interpret the measurement of DXA
- History of bariatric surgery: adjustable gastric banding, vertical banded gastrectomy ...
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 |
|---|---|---|
| protein supplementationProtein supplementation : Protein intake of 30 grams of protein in addition to the usual inputs (to the recommended amounts of 60 to 120 g per day), upon the resumption of oral intake until the fifth week after sleeve gastrectomy. | Other | care of with usual dietary protein supplementation |
Primary outcome
Changes in lean mass (kg) will be assessed at the level of whole-body dual-energy X-ray absorptiometry (DXA)
Time frame: up to 1 month
5 secondary outcomes
food diary
Time frame: 5 weeks after the hospital discharge
change rate IGF1, IGFBP3
Time frame: up to 1 month
the quality of life
Time frame: up to 1 month
the quality of life
Time frame: up to 5 years
change rate IGF1, IGFBP3
Time frame: up to 5 years
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 Jun 2026.
- Results publication: PubMed 37892386Maimoun L, Aouinti S, Puech M, Lefebvre P, Deloze M, de Santa Barbara P, Cristol JP, Brabant S, Gautier T, Nedelcu M, Renard E, Picot MC, Mariano-Goulart D, Nocca D. Effect of Nutritional Deprivation after Sleeve Gastrectomy on Bone Mass, Periostin, Sclerostin and Semaphorin 4D: A Two-Year Longitudinal Study. Nutrients. 2023 Oct 10;15(20):4310. doi: 10.3390/nu15204310.
- Results publication: PubMed 36904198Maimoun L, Aouinti S, Puech M, Lefebvre P, Deloze M, de Santa Barbara P, Renard E, Christol JP, Myzia J, Picot MC, Mariano-Goulart D, Nocca D. Changes in Lean Tissue Mass, Fat Mass, Biological Parameters and Resting Energy Expenditure over 24 Months Following Sleeve Gastrectomy. Nutrients. 2023 Feb 27;15(5):1201. doi: 10.3390/nu15051201.
- Results publication: PubMed 39693376Maimoun L, Aouinti S, Puech M, Lefebvre P, Humbert L, Deloze M, de Santa Barbara P, Maimoun-Nande L, Boudousq V, Cristol JP, Renard E, Picot MC, Mariano-Goulart D, Nocca D. Modification of bone architecture following sleeve gastrectomy: a five-year follow-up. J Bone Miner Res. 2025 Feb 2;40(2):251-261. doi: 10.1093/jbmr/zjae202.
- Individual participant dataSharing planned: Undecided
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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.
David NOCCA principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein supplementation in people with Obesity, run by University Hospital, Montpellier at 1 site in France.
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 4 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 Jun 2026. 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 France. 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?
Changes in lean mass (kg) will be assessed at the level of whole-body dual-energy X-ray absorptiometry (DXA) (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712086, which also lists 3 linked publications.
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 Jun 2026.