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

Study Overview
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Brief Summary
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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
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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;

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

Conditions
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Bariatric Surgery, Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Maltodextrin
* Dietary Supplement: Whey


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* Bariatric patients with or without sarcopenia receiving maltodextrin<br>|
| Experimental: Whey<br>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<br>* Bariatric patients with or without sarcopenia receiving whey protein<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, sarcopenia, bariatric surgery, protein