Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control group (CTRL) Patients allocated to this arm will not receive any intervention. |
|
| Experimental: 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. |
Dietary Supplement: Protein supplement
40g of whey protein in the breakfast;
|
| Placebo Comparator: 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. |
Dietary Supplement: isocaloric supplement
42g of isocaloric supplement in the breakfast;
|
Outcome Measures
Primary Outcome Measures
- Fat-free mass [16 weeks]
Fat-free mass evaluated trough dual-energy x-ray absorptiometry (DEXA)
Secondary Outcome Measures
- 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
- 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
- Insulin sensitivity as assessed by surrogates of insulin sensitivity [16 weeks]
Oral glucose tolerance test
Other Outcome Measures
- Lipid profile [16 weeks]
Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) will be evaluated by colorimetric enzymatic methods
- Inflammatory profile [16 weeks]
Inflammatory profile (i.e.; IL1β, IL-10, IL-6, IL-4, TNF-α and C-Reactive Protein) will be quantified using the Luminex xMAP technology
- Bone turnover [16 weeks]
Bone turnover (i.e.; CTX, P1NP, DKK1, sclerostin, osteocalcin, and osteopontin) will be quantified using the - Luminex xMAP technology;
- Brachial flow-mediated dilation (FMD) [16 weeks]
Brachial flow-mediated dilation (FMD) will be assessed by High-resolution B-mode ultrasound
- Cardiometabolic Risk Score [16 weeks]
Cardiometabolic Risk Score will be assessed by clustered cardiometabolic risk index
- Quadriceps cross-sectional area (CSA) [16 weeks]
Quadriceps cross-sectional area (CSA) will be assessed by computed tomography imaging
- Muscle fiber cross-sectional area (fCSA) [16 weeks]
Muscle fiber cross-sectional area (fCSA) will be assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
- Satellite cell content (SC) and myonuclei content [16 weeks]
Satellite cell content (SC) and myonuclei content will be assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
- Muscle fibre capillarization [16 weeks]
Muscle fibre capillarization will be assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
- Oxidative stress [16 weeks]
Oxidative stress (i.e,; SOD, CAT, glutathione, GPx, GSH and MDA) will be determined through ELISA assay.
- Gut hormones [16 weeks]
Gut hormones (i.e.; Ghrelin, GIP, GLP-1, PP, PYY) will be quantified using the Luminex xMAP technology
- Telomere length [16 weeks]
Telomere length will be assessed by quantitative real-time PCR
- Anxiety [16 weeks]
Anxiety will be assessed by the Geriatric Anxiety Inventory (GAI)
- Depression [16 weeks]
Depression will be assessed by the Geriatric Depression Scale (GDS)
- Ccognitive processing speed [16 weeks]
Cognitive processing speed will be assessed by Trail Making Test (TMT).
- Cognitive executive function [16 weeks]
Cognitive executive function will be assessed by Stroop Test (Victoria version)
- Sleep Quality [16 weeks]
Sleep Quality will be assessed by Pittsburgh Sleep Quality Index(TMT).
- Health-related quality of life [16 weeks]
Health-related quality of life will be evaluated by 36-Item Short Form Health Survey questionnaire (SF-36)
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Sao Paulo | São Paulo | Brazil | 05508-030 |
Sponsors and Collaborators
- University of Sao Paulo General Hospital
Investigators
- Principal Investigator: Hamilton Roschel, Phd, University of Sao Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 04234918.1.0000.0065