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Completed

NCT Number: NCT02712086

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHMontpellier

Montpellier, France, 34295

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ...

Treatment and study plan

protein supplementation

Other

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.

Primary outcomes

  1. 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

  1. food diary

    Time frame: 5 weeks after the hospital discharge

    The actual protein intake will be assessed using a food diary over 5 weeks completed by the patient

  2. change rate IGF1, IGFBP3

    Time frame: up to 1 month

    change rate IGF1, IGFBP3 between hospitalization and 1 month of hospital discharge

  3. the quality of life

    Time frame: up to 1 month

    The evolution of the quality of life will be assessed through a specific scale, Baros score.

  4. the quality of life

    Time frame: up to 5 years

    The evolution of the quality of life will be assessed through a specific scale, Baros score.

  5. change rate IGF1, IGFBP3

    Time frame: up to 5 years

    change rate IGF1, IGFBP3 between hospitalization and 5 years follow up

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: PROTISLEEVE

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2016
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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