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

NCT04510389 | Completed

• 1 other identifier: JLeite
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bariatric Surgery; Sarcopenia

Keywords

obesity; sarcopenia; bariatric surgery; protein

Outcome Measures

Primary Outcomes (2)

• Body Weight variation

  measured in scale presented in kg

  8th week

• Muscle mass

  measure by portable US

  8th week

Secondary Outcomes (6)

• Body Weight variation

  4th week

• Resting metabolic rate

  4th week

• Muscle mass

  4th week

• SNP (FTO) detection

  1st week

• Serum albumin

  4th week

Study Arms (2)

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.

Dietary Supplement: Maltodextrin

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.

Dietary Supplement: Whey

Interventions

Maltodextrin DIETARY_SUPPLEMENT

Bariatric patients with or without sarcopenia receiving maltodextrin

Placebo

Whey DIETARY_SUPPLEMENT

Bariatric patients with or without sarcopenia receiving whey protein

Whey

Eligibility Criteria

• Age: 20 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes over 20 years of age
• Patients with regular follow-up in the postoperative period.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Laboratório de Aterosclerose e Bioquimica Nutricional

Belo Horizonte, Minas Gerais, 30161-970, Brazil

Location

MeSH Terms

Conditions

Sarcopenia; Obesity

Interventions

maltodextrin; Whey

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: randomized

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: August 12, 2020
• Study Start: March 1, 2019
• Primary Completion: February 1, 2023
• Study Completion: February 14, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)