Clinical trial NCT02712086: Controlled Trial Evaluating the Efficacy of Protein Supplementation in the Short Term After Bariatric Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* surgical management of sleeve gastrectomy kind

Exclusion Criteria:

* 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 ...

Primary outcomes:
measure: Changes in lean mass (kg) will be assessed at the level of whole-body dual-energy X-ray absorptiometry (DXA)
timeFrame: up to 1 month
Secondary outcomes:
measure: food diary
timeFrame: 5 weeks after the hospital discharge
measure: change rate IGF1, IGFBP3
timeFrame: up to 1 month
measure: the quality of life
timeFrame: up to 1 month
measure: the quality of life
timeFrame: up to 5 years
measure: change rate IGF1, IGFBP3
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UHMontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: David NOCCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maimoun 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.
citation: Maimoun 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.