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

Primary Purpose

Bariatric Surgery, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Maltodextrin
Whey
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery focused on measuring obesity, sarcopenia, bariatric surgery, protein

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Laboratório de Aterosclerose e Bioquimica Nutricional

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Whey

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Body Weight variation
measured in scale presented in kg
Muscle mass
measure by portable US

Secondary Outcome Measures

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

Full Information

First Posted
January 18, 2019
Last Updated
February 14, 2023
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT04510389
Brief Title
Impact of Whey Protein Supplementation on Body Weight and Metabolic Parameters of Bariatric Patients
Official Title
Impact of Whey Protein Supplementation on Body Composition, Energy Expenditure and Biochemical Parameters of Patients Submitted to Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Sarcopenia
Keywords
obesity, sarcopenia, bariatric surgery, protein

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized
Masking
ParticipantInvestigator
Masking Description
Patient will receive indistinguishable sachets containing 30g of maltodextrin (placebo) or 30g whey protein. The sachets codification and patient allocation will be prepared by an individual without any contact with patients or the team which will follow patients
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Whey
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Bariatric patients with or without sarcopenia receiving maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey
Intervention Description
Bariatric patients with or without sarcopenia receiving whey protein
Primary Outcome Measure Information:
Title
Body Weight variation
Description
measured in scale presented in kg
Time Frame
8th week
Title
Muscle mass
Description
measure by portable US
Time Frame
8th week
Secondary Outcome Measure Information:
Title
Body Weight variation
Description
measured in scale presented in kg
Time Frame
4th week
Title
Resting metabolic rate
Description
measured by indirect calorimetry in kcal/kg/day
Time Frame
4th week
Title
Muscle mass
Description
measure by portable US
Time Frame
4th week
Title
SNP (FTO) detection
Description
measure by polymerase chain reaction (PCR) in present or absence of A and T allele
Time Frame
1st week
Title
Serum albumin
Description
measured in serum in g/dL
Time Frame
4th week
Title
Serum albumin
Description
measured in serum in g/dL
Time Frame
8th week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Laboratório de Aterosclerose e Bioquimica Nutricional
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30161-970
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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