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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.
Specific objectives:
It is also objective to evaluate:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
|
| Whey | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maltodextrin | Dietary Supplement | Bariatric patients with or without sarcopenia receiving maltodextrin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight variation | measured in scale presented in kg | 8th week |
| Muscle mass | measure by portable US | 8th week |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratório de Aterosclerose e Bioquimica Nutricional | Belo Horizonte | Minas Gerais | 30161-970 | Brazil |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D000067796 | Whey |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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randomized
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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
| Whey | Dietary Supplement | Bariatric patients with or without sarcopenia receiving whey protein |
|
| 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 |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |