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Controlled Trial Evaluating the Efficacy of Protein Supplementation in the Short Term After Bariatric Surgery (PROTISLEEVE)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Obesity

Treatments

Other: protein supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT02712086
UF 9590 (Other Identifier)
RECHMPL15_0173

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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 ...

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

usual dietary management
No Intervention group
Description:
Control group: usual dietary management Following the intervention, the stomach of patients underwent many changes
care of with usual dietary protein supplementation
Experimental group
Description:
Intervention group: Usual dietary management with protein supplementation (30g) in addition to the usual inputs
Treatment:
Other: protein supplementation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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