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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: protein supplementation

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 ...

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual dietary management; Control group: usual dietary management Following the intervention, the stomach of patients underwent many changes
Experimental: care of with usual dietary protein supplementation; Intervention group: Usual dietary management with protein supplementation (30g) in addition to the usual inputs	Other: protein supplementation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in lean mass (kg) will be assessed at the level of whole-body dual-energy X-ray absorptiometry (DXA)	up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
food diary	The actual protein intake will be assessed using a food diary over 5 weeks completed by the patient	5 weeks after the hospital discharge
change rate IGF1, IGFBP3	change rate IGF1, IGFBP3 between hospitalization and 1 month of hospital discharge	up to 1 month
the quality of life	The evolution of the quality of life will be assessed through a specific scale, Baros score.	up to 1 month
the quality of life	The evolution of the quality of life will be assessed through a specific scale, Baros score.	up to 5 years
change rate IGF1, IGFBP3	change rate IGF1, IGFBP3 between hospitalization and 5 years follow up	up to 5 years

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: David NOCCA, University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2016
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 16, 2016
• First Posted (Estimated): March 17, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RECHMPL15_0173; UF 9590 (Other Identifier: Montpellier University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED