Clinical trial NCT04981366: Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise
Official title: Effects of the Protein Supplementation Associated With Exercise Training in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenic Obesity
Aging
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 105
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Fat-free Mass
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Appendicular Fat-free Mass
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Appendicular Fat-free Mass to Body Mass Index Ratio
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Leg Fat-free Mass
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Secondary outcomes:
measure: Fat-mass
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Quadriceps Cross-sectional Area (CSA)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Rectus Femoris Cross-sectional Area (CSA)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Vastus Lateralis Cross-sectional Area (CSA)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Muscle Fiber Cross-sectional Area (fCSA)- Type I
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Muscle Fiber Cross-sectional Area (fCSA)- Type II
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Mineral Density (Whole-body)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Mineral Density (Femur Neck)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Mineral Density (Total Hip)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Mineral Density (Lumbar Spine)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Microarchitecture (Total Volumetric Density)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Microarchitecture (Trabecular Volumetric Density)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Microarchitecture (Cortical Volumetric Density)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Microarchitecture (BV/TV)
timeFrame: 16 weeks
measure: Bone Microarchitecture (Trabecular Number - Tb. N)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Microarchitecture (Trabecular Separation)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Microarchitecture (Trabecular Thickness)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Microarchitecture (Cortical Porosity)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Microarchitecture (Cortical Thickness)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Microarchitecture (Cortical Pore Diameter)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Microarchitecture (Stiffness)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Bone Microarchitecture (Estimated Failure Load)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Isometric Muscle Strength - Handgrip
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Muscle Strength - Upper Limbs
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Muscle Strength - Lower Limbs
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Muscle Function (Short Physical Performance Battery)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Muscle Function (30-s Sit-to-stand Test)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Muscle Function (Timed-up-and-go)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Muscle Function (Gait Speed)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Cardiorespiratory Fitness
timeFrame: 16 weeks
measure: Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Brachial Flow-mediated Dilation (FMD)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Other outcomes:
measure: Lipid Profile (HDL)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Lipid Profile (LDL)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Lipid Profile (VLDL)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Lipid Profile (Triglycerides)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Telomere Length
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Oxidative Stress - Superoxide Dismutase
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Oxidative Stress - Catalase Activity
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Oxidative Stress - Glutathione Peroxidase
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Oxidative Stress - Glutathione Reductase
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Oxidative Stress - Glutathione S-transferases
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Oxidative Stress - Thiobarbituric Acid Reactive Substances
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Inflammatory Profile - IL1β
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Inflammatory Profile - IL-10
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Inflammatory Profile - IL-6
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Inflammatory Profile - TNF-α
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Inflammatory Profile - C-Reactive Protein
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Area Under the Curve (AUC) of Blood Glucose
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Area Under the Curve (AUC) of Insulin
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Anxiety
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Depression
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Health-related Quality of Life - Physical Component
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Health-related Quality of Life - Mental Component
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Sleep Quality
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Hamilton Roschel, Phd
role: PRINCIPAL_INVESTIGATOR
References: