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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of the Protein Supplementation Associated With Exercise Training in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction

Conditions
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Sarcopenic Obesity, Aging

Intervention / Treatment
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* Dietary Supplement: Protein supplement
* Dietary Supplement: isocaloric supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group (CTRL)<br>Patients allocated to this arm will not receive any intervention. | |
| Experimental: Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN)<br>Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus protein supplementation. | Dietary Supplement: Protein supplement<br>* 40g of whey protein in the breakfast;<br>|
| Placebo Comparator: Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA)<br>Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus isocaloric placebo. | Dietary Supplement: isocaloric supplement<br>* 42g of isocaloric supplement in the breakfast;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat-free mass | Fat-free mass evaluated trough dual-energy x-ray absorptiometry (DEXA) | 16 weeks | 

Secondary Outcome Measures

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