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

Not Applicable

Completed

• Conditions: Sarcopenia; Bariatric Surgery
• Interventions: Dietary Supplement: Whey; Dietary Supplement: Maltodextrin

• Registration Number: NCT04510389
• Lead Sponsor: Federal University of Minas Gerais

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;

Study Timeline

• Study First Submitted: 2019-01-18
• Study Start: 2019-03-01
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-12
• Status Verified: 2023-02
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-14
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whey	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.
Placebo	Maltodextrin	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.

Primary Outcome Measures

Name	Time	Method
Muscle mass	8th week	measure by portable US
Body Weight variation	8th week	measured in scale presented in kg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Laboratório de Aterosclerose e Bioquimica Nutricional; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil