An interventional study of Maltodextrin and Whey in Bariatric Surgery and Sarcopenia, sponsored by Federal University of Minas Gerais. Completed at 1 site in Brazil. Open to female participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Treatment
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:
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Federal University of Minas Gerais is the lead sponsor of 150 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 maltodextrin
Bariatric patients with or without sarcopenia receiving whey protein
Body Weight variation
measured in scale presented in kg
Time frame: 8th week
Muscle mass
measure by portable US
Time frame: 8th week
Body Weight variation
measured in scale presented in kg
Time frame: 4th week
Resting metabolic rate
measured by indirect calorimetry in kcal/kg/day
Time frame: 4th week
Muscle mass
measure by portable US
Time frame: 4th week
SNP (FTO) detection
measure by polymerase chain reaction (PCR) in present or absence of A and T allele
Time frame: 1st week
Serum albumin
measured in serum in g/dL
Time frame: 4th week
Serum albumin
measured in serum in g/dL
Time frame: 8th week
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Federal University of Minas Gerais