Effects of the Protein Supplementation Associated With Exercise Training in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sarcopenic Obesity
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Percentage of Fat-free Mass
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Hamilton Augusto Roschel da Silva
Principal Investigator
University of Sao Paulo General Hospital
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.
Outcomes
Primary Outcomes
Percentage of Fat-free Mass
Time Frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Fat-free mass evaluated through dual-energy x-ray absorptiometry (DEXA) and reported as percentage
Appendicular Fat-free Mass
Time Frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the upper and lower limbs.
Appendicular Fat-free Mass to Body Mass Index Ratio
Time Frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
The appendicular fat-free mass (AFFM) was assessed using dual-energy X-ray absorptiometry (DXA) and expressed in kilograms (kg). The body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters (kg/m²). The AFFM/BMI ratio was computed by dividing AFFM (kg) by BMI (kg/m²), resulting in a unitless ratio. Higher values indicate greater muscle mass relative to body size
Leg Fat-free Mass
Time Frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the lower limbs.
Secondary Outcomes
- Bone Microarchitecture (Cortical Pore Diameter)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Fat-mass(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Quadriceps Cross-sectional Area (CSA)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Rectus Femoris Cross-sectional Area (CSA)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Vastus Lateralis Cross-sectional Area (CSA)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Muscle Fiber Cross-sectional Area (fCSA)- Type I(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Muscle Fiber Cross-sectional Area (fCSA)- Type II(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Mineral Density (Whole-body)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Mineral Density (Femur Neck)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Mineral Density (Total Hip)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Mineral Density (Lumbar Spine)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Microarchitecture (Total Volumetric Density)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Microarchitecture (Trabecular Volumetric Density)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Microarchitecture (Cortical Volumetric Density)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Microarchitecture (BV/TV)(16 weeks)
- Bone Microarchitecture (Trabecular Number - Tb. N)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Muscle Function (30-s Sit-to-stand Test)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Microarchitecture (Trabecular Separation)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Microarchitecture (Trabecular Thickness)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Muscle Function (Short Physical Performance Battery)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Muscle Function (Gait Speed)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Microarchitecture (Cortical Porosity)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Microarchitecture (Cortical Thickness)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Microarchitecture (Stiffness)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Muscle Function (Timed-up-and-go)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Bone Microarchitecture (Estimated Failure Load)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Isometric Muscle Strength - Handgrip(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Muscle Strength - Upper Limbs(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Muscle Strength - Lower Limbs(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Cardiorespiratory Fitness(16 weeks)
- Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity(Baseline (Pre-intervention) and 16 weeks (Post-intervention))
- Brachial Flow-mediated Dilation (FMD)(Baseline (Pre-intervention) and 16 weeks (Post-intervention))