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

NCT ID: NCT04510389

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2023-02-14

Brief 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;

Conditions

Bariatric Surgery; Sarcopenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

volunteers will receive 28 sachets containing 30g of maltodextrin to be consumed daily for 4 weeks. After that they will return to the 4-week visit and assessment when they will receive 28 sachets for the next 28 days when will return for the final vist and assessment.

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Bariatric patients with or without sarcopenia receiving maltodextrin

Whey

volunteers will receive 28 sachets containing 30g of whey protein to be consumed daily for 4 weeks. After that they will return to the 4-week visit and assessment when they will receive 28 sachets for the next 28 days when will return for the final vist and assessment.

Group Type: EXPERIMENTAL

Whey

Intervention Type: DIETARY_SUPPLEMENT

Bariatric patients with or without sarcopenia receiving whey protein

Interventions

Maltodextrin

Bariatric patients with or without sarcopenia receiving maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Whey

Bariatric patients with or without sarcopenia receiving whey protein

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Jacqueline Isaura Alvarez Leite

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Laboratório de Aterosclerose e Bioquimica Nutricional

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

JLeite

Identifier Type: -

Identifier Source: org_study_id