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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510389
• Other study ID #: JLeite
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: February 14, 2023

Study information

• Verified date: February 2023
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 14, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Sarcopenia

Intervention

Dietary Supplement:
• Maltodextrin
Bariatric patients with or without sarcopenia receiving maltodextrin
• Whey
Bariatric patients with or without sarcopenia receiving whey protein

Locations

Country	Name	City	State
Brazil	Laboratório de Aterosclerose e Bioquimica Nutricional	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight variation	measured in scale presented in kg	8th week
Primary	Muscle mass	measure by portable US	8th week
Secondary	Body Weight variation	measured in scale presented in kg	4th week
Secondary	Resting metabolic rate	measured by indirect calorimetry in kcal/kg/day	4th week
Secondary	Muscle mass	measure by portable US	4th week
Secondary	SNP (FTO) detection	measure by polymerase chain reaction (PCR) in present or absence of A and T allele	1st week
Secondary	Serum albumin	measured in serum in g/dL	4th week
Secondary	Serum albumin	measured in serum in g/dL	8th week