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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Other: protein supplementation


Participation Criteria
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Eligibility Criteria
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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 ...

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |