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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Bariatric Surgery
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: Whey

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30161-970
      • Laboratório de Aterosclerose e Bioquimica Nutricional

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Dietary supplement: Maltodextrin; Bariatric patients with or without sarcopenia receiving maltodextrin
Experimental: 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.	Dietary supplement: Whey; Bariatric patients with or without sarcopenia receiving whey protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight variation	measured in scale presented in kg	8th week
Muscle mass	measure by portable US	8th week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery; sarcopenia; protein
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: JLeite

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No