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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: protein supplementation

• Registration Number: NCT02712086
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-17
• Study Start: 2016-10-19
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
care of with usual dietary protein supplementation	protein supplementation	Intervention group: Usual dietary management with protein supplementation (30g) in addition to the usual inputs

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

UHMontpellier; 🇫🇷 Montpellier, France