NCT02712086: PROTISLEEVE

Controlled Trial Evaluating the Efficacy of Protein Supplementation in the Short Term After Bariatric Surgery

Completed NA Last updated 2 April 2025

What this trial tests

NA trial testing protein supplementation in Obesity in 90 participants. Completed in 30 October 2023.

Timeline

19 October 2016

Primary endpoint
30 October 2023

30 October 2023

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	90
Start date	19 October 2016
Primary completion	30 October 2023
Estimated completion	30 October 2023
Sites	1 location across France

Drugs / interventions tested

• protein supplementation

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

University Hospital, Montpellier

Who can join

Adults 18 to 60, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Changes in Lean Tissue Mass, Fat Mass, Biological Parameters and Resting Energy Expenditure over 24 Months Following Sleeve Gastrectomy.
   Maïmoun L, Aouinti S, Puech M, Lefebvre P, et al · · 2023 · cited 3× · PMID 36904198 · DOI 10.3390/nu15051201
2. Effect of Nutritional Deprivation after Sleeve Gastrectomy on Bone Mass, Periostin, Sclerostin and Semaphorin 4D: A Two-Year Longitudinal Study.
   Maïmoun L, Aouinti S, Puech M, Lefebvre P, et al · · 2023 · cited 2× · PMID 37892386 · DOI 10.3390/nu15204310