Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04510389
Other study ID # JLeite
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date February 14, 2023

Study information

Verified date February 2023
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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;


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 14, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Maltodextrin
Bariatric patients with or without sarcopenia receiving maltodextrin
Whey
Bariatric patients with or without sarcopenia receiving whey protein

Locations

Country Name City State
Brazil Laboratório de Aterosclerose e Bioquimica Nutricional Belo Horizonte Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Weight variation measured in scale presented in kg 8th week
Primary Muscle mass measure by portable US 8th week
Secondary Body Weight variation measured in scale presented in kg 4th week
Secondary Resting metabolic rate measured by indirect calorimetry in kcal/kg/day 4th week
Secondary Muscle mass measure by portable US 4th week
Secondary SNP (FTO) detection measure by polymerase chain reaction (PCR) in present or absence of A and T allele 1st week
Secondary Serum albumin measured in serum in g/dL 4th week
Secondary Serum albumin measured in serum in g/dL 8th week
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06287502 - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis N/A
Recruiting NCT05063279 - RELIEF - Resistance Training for Life N/A
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Recruiting NCT06143592 - Inspiratory Muscle Training on Balance, Falls and Diaphragm Thickness in the Elderly N/A
Terminated NCT04350762 - Nutritional Supplementation in the Elderly With Weight Loss N/A
Enrolling by invitation NCT05953116 - Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health Study N/A
Recruiting NCT04028206 - Resistance Exercise or Vibration With HMB for Sarcopenia N/A
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A
Completed NCT03234920 - Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation After Liver Transplantation N/A
Recruiting NCT03998202 - Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Recruiting NCT04717869 - Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
Completed NCT05497687 - Strength-building Lifestyle-integrated Intervention N/A
Completed NCT03119610 - The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity Phase 1/Phase 2
Recruiting NCT05711095 - The Anabolic Properties of Fortified Plant-based Protein in Older People N/A
Recruiting NCT05008770 - Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Recruiting NCT04522609 - Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant N/A
Recruiting NCT04545268 - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance N/A
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease