Obesity
Conditions
Keywords
Obesity, Gastric by-pass, Body composition, Nutrition, Physical activity
Brief summary
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
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.
Interventions
BEHAVIORALProtein supplementation and strength training
Protein supplementation and strength training
DIETARY_SUPPLEMENTProtein supplementation
Protein supplementation
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in fat-free mass at 6 months | 6 months |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed