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NCT Number: NCT04510389

Impact of Whey Protein Supplementation on Body Weight and Metabolic Parameters of Bariatric Patients

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.

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Key information

Conditions

Bariatric Surgery Atrophy Body Weight Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laboratório de Aterosclerose e Bioquimica Nutricional

Belo Horizonte, Minas Gerais, 30161-970, Brazil

About this study

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;

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients of both sexes over 20 years of age
  • Patients with regular follow-up in the postoperative period.

Exclusion criteria

  • Patients with debilitating chronic diseases
  • Severe vomiting
  • Submitted to other surgical procedures before 18 months of surgery
  • Patient with prostheses
  • Use or introduction of drugs immunosuppressants or affecting metabolism

Treatment and study plan

Maltodextrin

Dietary Supplement

Bariatric patients with or without sarcopenia receiving maltodextrin

Whey

Dietary Supplement

Bariatric patients with or without sarcopenia receiving whey protein

Primary outcomes

  1. Body Weight variation

    Time frame: 8th week

    measured in scale presented in kg

  2. Muscle mass

    Time frame: 8th week

    measure by portable US

Secondary outcomes

  1. Body Weight variation

    Time frame: 4th week

    measured in scale presented in kg

  2. Resting metabolic rate

    Time frame: 4th week

    measured by indirect calorimetry in kcal/kg/day

  3. Muscle mass

    Time frame: 4th week

    measure by portable US

  4. SNP (FTO) detection

    Time frame: 1st week

    measure by polymerase chain reaction (PCR) in present or absence of A and T allele

  5. Serum albumin

    Time frame: 4th week

    measured in serum in g/dL

  6. Serum albumin

    Time frame: 8th week

    measured in serum in g/dL

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Impact of Whey Protein Supplementation on Body Composition, Energy Expenditure and Biochemical Parameters of Patients Submitted to Bariatric Surgery

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2020
Registry last updated
Feb 16, 2023

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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