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

Not Applicable

Completed

• Conditions: Sarcopenic Obesity; Aging
• Interventions: Dietary Supplement: Protein supplement; Dietary Supplement: isocaloric supplement

• Registration Number: NCT04981366
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-29
• Study Start: 2021-08-01
• Primary Completion: 2023-08-21
• Study Completion: 2023-08-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN)	Protein supplement	Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus protein supplementation.
Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA)	isocaloric supplement	Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus isocaloric placebo.

Primary Outcome Measures

Name	Time	Method
Fat-free mass	16 weeks	Fat-free mass evaluated trough dual-energy x-ray absorptiometry (DEXA)

Secondary Outcome Measures

Name	Time	Method
Muscle strength	16 weeks	Muscle strength will be evaluated using maximal dynamic strength test \[1RM\])
Cardiorespiratory fitness	16 weeks	Cardiorespiratory fitness will be evaluated by maximal oxygen uptake (VO²max) during a maximal exercise test on a treadmill
Fat-mass	16 weeks	Fat mass evaluated trough dual-energy x-ray absorptiometry (DEXA)
bone mineral density	16 weeks	bone mineral density evaluated trough dual-energy x-ray absorptiometry (DEXA)
Bone microarchitecture	16 weeks	Bone microarchitecture will be assessed using a high resolution peripheral quantitative computed tomography (HR-pQCT)
Muscle function	16 weeks	Muscle function evaluated trough battery of tests
Insulin sensitivity as assessed by surrogates of insulin sensitivity	16 weeks	Oral glucose tolerance test

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 São Paulo, Brazil