Obesity
Conditions
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.
Interventions
OTHERprotein 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.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 ...
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 1 month | change rate IGF1, IGFBP3 between hospitalization and 1 month of hospital discharge |
| the quality of life | up to 1 month | The evolution of the quality of life will be assessed through a specific scale, Baros score. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORDavid NOCCA
University Hospital, Montpellier
Outcome results
None listed