Controlled Trial Evaluating the Efficacy of Protein Supplementation in the Short Term After Bariatric Surgery
Keywords
Abstract
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.
Dates
| Last Verified: | 12/31/2019 |
| First Submitted: | 03/13/2016 |
| Estimated Enrollment Submitted: | 03/15/2016 |
| First Posted: | 03/16/2016 |
| Last Update Submitted: | 01/06/2020 |
| Last Update Posted: | 01/09/2020 |
| Actual Study Start Date: | 10/18/2016 |
| Estimated Primary Completion Date: | 09/30/2020 |
| Estimated Study Completion Date: | 07/31/2021 |
Condition or disease
Intervention/treatment
Other: care of with usual dietary protein supplementation
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| No Intervention: usual dietary management Control group: usual dietary management Following the intervention, the stomach of patients underwent many changes | |
| Experimental: care of with usual dietary protein supplementation Intervention group: Usual dietary management with protein supplementation (30g) in addition to the usual inputs | Other: care of with usual dietary protein 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 ... |
Outcome
Primary Outcome Measures
1. 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
1. food diary [5 weeks after the hospital discharge]
2. change rate IGF1, IGFBP3 [up to 1 month]
3. the quality of life [up to 1 month]
