Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise

NCT ID: NCT04981366

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-08-25

Brief Summary

This study aims to investigate if protein supplementation increases the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.

Detailed Description

A major subset of adults over the age of 65 is now classified as having sarcopenic obesity, a high-risk geriatric syndrome predominantly observed in an aging population that is at risk of synergistic complications from both sarcopenia and obesity.

Lifestyle interventions such as caloric restriction and exercise training are effective nonpharmacological strategies to mitigate some adverse effects related to this condition. Also, protein supplementation may boost the benefits of exercise, but this assumption is still to be tested. This trial aims to test whether protein supplementation is able to increase the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.

Conditions

Sarcopenic Obesity; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group (CTRL)

Patients allocated to this arm will not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN)

Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus protein supplementation.

Group Type: EXPERIMENTAL

Protein supplement

Intervention Type: DIETARY_SUPPLEMENT

40g of whey protein in the breakfast;

Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA)

Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus isocaloric placebo.

Group Type: PLACEBO_COMPARATOR

isocaloric supplement

Intervention Type: DIETARY_SUPPLEMENT

42g of isocaloric supplement in the breakfast;

Interventions

Protein supplement

40g of whey protein in the breakfast;

Intervention Type: DIETARY_SUPPLEMENT

isocaloric supplement

42g of isocaloric supplement in the breakfast;

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 65 years and older;
• Body mass index (BMI) > 30 kg/m2;
• Sarcopenia;
• not engage into exercise training programas.

Exclusion Criteria

• cancer in the last 5 years;
• cognitive deficit or dementia that impossibility the patient to read and sign the informed consent form;
• any disease that limits participation in exercise training program.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hamilton Augusto Roschel da Silva

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hamilton Roschel, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo

São Paulo, , Brazil

Countries

Brazil

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

04234918.1.0000.0065

Identifier Type: -

Identifier Source: org_study_id