Impact of Whey Protein Supplementation on Body Weight & Metabolic

Status Completed

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.

Clinical Trial 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; ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04510389
Study type	Interventional
Source	Federal University of Minas Gerais
Contact
Status	Completed
Phase	N/A
Start date	March 1, 2019
Completion date	February 14, 2023

View Details

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	`NCT04545268` - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance	N/A
Recruiting	`NCT04522609` - Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant	N/A
Recruiting	`NCT03160326` - The QUALITY Vets Project: Muscle Quality and Kidney Disease

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms