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Clinical Trials/NCT02712086
NCT02712086
Completed
Not Applicable

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

University Hospital, Montpellier1 site in 1 country90 target enrollmentOctober 19, 2016
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University Hospital, Montpellier
Enrollment
90
Locations
1
Primary Endpoint
Changes in lean mass (kg) will be assessed at the level of whole-body dual-energy X-ray absorptiometry (DXA)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 19, 2016
End Date
October 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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 ...

Outcomes

Primary Outcomes

Changes in lean mass (kg) will be assessed at the level of whole-body dual-energy X-ray absorptiometry (DXA)

Time Frame: up to 1 month

Secondary Outcomes

  • the quality of life(up to 5 years)
  • food diary(5 weeks after the hospital discharge)
  • change rate IGF1, IGFBP3(up to 5 years)

Study Sites (1)

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