Impact of Whey Protein Supplementation on Body Weight and Metabolic Parameters of Bariatric Patients
Condition: Bariatric Surgery; Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Obesity is a metabolic disorder, characterized by an increase in the body's fat mass, which
      will reflect an increase in total body weight. In Brazil, overweight accounts for 53.8% of
      the population, and of these 18.9% are obese. Surgical treatment is currently the most
      successful method for weight loss in patients with Grade III obesity and reduced associated
      morbidities. The general objective is to evaluate genetic, inflammatory, and dietary factors
      that would influence weight loss and the appearance of protein deficiency or sarcopenia in
      patients undergoing bariatric surgery and to evaluate the effects of protein supplementation
      for 8 weeks after the 18th postoperative month in the parameters evaluated. The study has a
      randomized, placebo-controlled, double-masked model. The patients will be selected in two
      bariatric surgery services accredited by the Brazilian Health Unic System (SUS) in the city
      of Belo Horizonte, Brazil.

      The project has already been approved by the Brazilian Ethics committee CONEP/UFMG by nº.
      75415317.8.0000.5149. Patients of both sexes over 20 years of age will be included, attending
      the hospitals of the project with regular follow-up in the postoperative period. Data on
      anthropometry, body composition, muscle strength, energy expenditure, and inflammatory
      profile will be collected. The data will be correlated with the evaluation of the presence of
      genetic polymorphisms.
    

Detailed description: 
      Specific objectives:

      It is also objective to evaluate:

        -  To observe the food consumption between 18 and 24 months of surgery with respect to
           protein and caloric intake;

        -  Evolution of weight loss, lean mass, fat mass and metabolic rate before and after
           supplementation with WP or placebo;

        -  Changes in protein status (assessed by muscle strength and serum levels of total
           protein, albumin, prealbumin, ferritin, hemoglobin) before and after supplementation
           with WP or placebo

        -  The inflammatory blood profile (assessed by cytokine levels and before and after
           supplementation with WP or placebo).

        -  The influence of the rS9939609 polymorphism of the FTO gene on the nutritional status,
           biochemical and inflammatory parameters in the postoperative (after 18 months) of
           surgery;
    

Intervention name(s): Maltodextrin; Whey
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Bariatric patients with or without sarcopenia receiving maltodextrin; Bariatric patients with or without sarcopenia receiving whey protein
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obesity; sarcopenia; bariatric surgery; protein