Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training (PROMISE)

Study Overview
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Brief Summary
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The purpose of the study is to test whether additional protein intake with or without strength training will help to maintain body composition (fat-free mass) after surgical treatment of obesity by gastric by pass. The main hypothesis is that additional protein intake will limit fat-free mass loss during surgery-induced weight loss, and that strength training will have an additional beneficial effect

Detailed Description
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Design: Open randomised controlled trial comparing, in obese patients after GBP, an additional oral intake of protein with or without a muscular-strengthening physical training programme (18 weeks) to standard medical and nutritional follow-up after bariatric surgery as control (3 groups). Primary outcome: Variation at 6 months after GBP in total and appendicular fat-free mass as assessed by dual-energy X-ray absorptiometry (DXA). Duration of the study: 36 months. Duration of participation for one patient: 7 months. Number of centers: Monocentric study.

Official Title
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Optimization of Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training: Interventional Randomized Trial

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Protein supplementation and strength training
* Dietary Supplement: Protein supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female gender Age between 18 and 60 years Planned obesity treatment by gastric bypass Written informed consent Exclusion Criteria: Subject not affiliated with a social security scheme Refusal Regular follow-up not feasible Participation in a structured physical activity program Recent coronary event Uncontrolled hypertension proliferative diabetic retinopathy or disabling neuropathy, treatment by dialysis, orthopedic problems Pregnancy Specific food intolerance to protein products Abnormal cardiac stress test

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

Sexes Eligible for Study
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Female

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: Standard treatment - usual care<br> | |
| Experimental: Protein supplementation<br> | Dietary Supplement: Protein supplementation<br>* Protein supplementation<br>|
| Experimental: Protein supplementation and strength training<br> | Behavioral: Protein supplementation and strength training<br>* Protein supplementation and strength training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fat-free mass at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation at 6 months after GBP of other body composition components |  | 6 months | 
| Variation at 6 months after GBP in dietary habits |  | 6 months | 
| Variation at 6 months after GBP in muscular strength and habitual physical activity |  | 6 months | 
| Variation at 6 months after GBP in quality of life and obesity co-morbidities |  | 6 months | 
| Variation at 6 months after GBP in obesity-associated inflammatory markers |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Gastric by-pass, Body composition, Nutrition, Physical activity