N/A
N=105
Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise
Sarcopenic Obesity · Aging
Bottom Line
View on ClinicalTrials.gov: NCT04981366 ↗Enrolled (actual)
105
Serious AEs
1.9%
Results posted
Jun 2025
Primary outcome: Primary: Percentage of Fat-free Mass — 49.6; 50.3; 50.5; 52.5 percentage of fat-free mass — p=0.013
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Protein supplement (Dietary_supplement); isocaloric supplement (Dietary_supplement)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo General Hospital
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Fat-free Mass |
49.6; 50.3; 50.5; 52.5; 52.7; 49.3 | 0.013 sig |
| PRIMARY Appendicular Fat-free Mass |
17.7; 18.0; 17.4; 18.1; 17.6; 16.5 | <0.001 sig |
| PRIMARY Appendicular Fat-free Mass to Body Mass Index Ratio |
0.49; 0.52; 0.51; 0.54; 0.54; 0.48 | <0.001 sig |
| PRIMARY Leg Fat-free Mass |
13.5; 13.5; 13.2; 13.8; 13.0; 12.5 | 0.007 sig |
| SECONDARY Fat-mass |
48.6; 47.8; 47.7; 45.6; 45.4; 48.9 | <0.001 sig |
| SECONDARY Quadriceps Cross-sectional Area (CSA) |
51.7; 50.7; 50.1; 54.3; 51.9; 47.7 | <0.001 sig |
| SECONDARY Rectus Femoris Cross-sectional Area (CSA) |
3.39; 3.23; 3.32; 3.45; 3.27; 3.10 | 0.005 sig |
| SECONDARY Vastus Lateralis Cross-sectional Area (CSA) |
12.32; 12.15; 12.13; 12.55; 12.45; 11.49 | <0.001 sig |
| SECONDARY Muscle Fiber Cross-sectional Area (fCSA)- Type I |
2240.7; 2725.8; 2669.4; 3108.6; 2859.4; 2614.6 | <0.001 sig |
| SECONDARY Muscle Fiber Cross-sectional Area (fCSA)- Type II |
2175.6; 2401.4; 2340.8; 2775.2; 2239.5; 2166.1 | <0.001 sig |
| SECONDARY Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I) |
0.34; 0.38; 0.35; 0.38; 0.46; 0.35 | <0.001 sig |
| SECONDARY Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP) |
53.1; 61.0; 56.3; 66.2; 66.1; 56.8 | 0.001 sig |
| SECONDARY Bone Mineral Density (Whole-body) |
1.08; 1.10; 1.05; 1.06; 1.08; 1.05 | 0.033 sig |
| SECONDARY Bone Mineral Density (Femur Neck) |
0.75; 0.75; 0.74; 0.74; 0.75; 0.74 | 0.944 |
| SECONDARY Bone Mineral Density (Total Hip) |
0.90; 0.93; 0.89; 0.90; 0.93; 0.88 | 0.203 |
| SECONDARY Bone Mineral Density (Lumbar Spine) |
0.98; 1.01; 0.96; 0.97; 1.00; 0.96 | 0.027 sig |
| SECONDARY Bone Microarchitecture (Total Volumetric Density) |
331.9; 309.5; 324.7; 340.2; 308.6; 328.9 | 0.145 |
| SECONDARY Bone Microarchitecture (Trabecular Volumetric Density) |
147.7; 309.5; 324.7; 152.0; 308.6; 328.9 | 0.001 sig |
| SECONDARY Bone Microarchitecture (Cortical Volumetric Density) |
969.9; 951.0; 972.8; 969.9; 948.7; 975.5 | 0.551 |
| SECONDARY Bone Microarchitecture (BV/TV) |
12.5; 12.9; 12.2; 12.7; 12.9; 12.3 | 0.001 sig |
| SECONDARY Bone Microarchitecture (Trabecular Number - Tb. N) |
1.86; 1.96; 1.90; 1.90; 1.93; 1.90 | 0.001 sig |
| SECONDARY Bone Microarchitecture (Trabecular Separation) |
0.493; 0.459; 0.488; 0.474; 0.474; 0.469 | 0.001 sig |
| SECONDARY Bone Microarchitecture (Trabecular Thickness) |
0.066; 0.066; 0.066; 0.064; 0.068; 0.067 | 0.008 sig |
| SECONDARY Bone Microarchitecture (Cortical Porosity) |
3.5; 3.5; 3.2; 3.1; 3.4; 3.5 | <0.001 sig |
| SECONDARY Bone Microarchitecture (Cortical Thickness) |
0.958; 0.827; 0.908; 0.968; 0.826; 0.911 | 0.344 |
| SECONDARY Bone Microarchitecture (Cortical Pore Diameter) |
0.168; 0.172; 0.169; 0.166; 0.174; 0.171 | 0.613 |
| SECONDARY Bone Microarchitecture (Stiffness) |
72.7; 74.1; 71.6; 73.5; 75.1; 69.7 | 0.944 |
| SECONDARY Bone Microarchitecture (Estimated Failure Load) |
3458; 3553; 3430; 3503; 3598; 3347 | 0.601 |
| SECONDARY Isometric Muscle Strength - Handgrip |
18.57; 19.29; 19.86; 23.17; 23.71; 18.43 | <0.001 sig |
| SECONDARY Muscle Strength - Upper Limbs |
21.9; 23.2; 23.2; 26.9; 28.1; 19.2 | <0.001 sig |
| SECONDARY Muscle Strength - Lower Limbs |
99.9; 99.6; 106.9; 120.8; 124.8; 94.3 | <0.001 sig |
| SECONDARY Muscle Function (Short Physical Performance Battery) |
8.9; 8.2; 9.3; 10.7; 10.9; 9.0 | — |
| SECONDARY Muscle Function (30-s Sit-to-stand Test) |
10.3; 9.4; 10.4; 12.8; 12.4; 10.2 | <0.001 sig |
| SECONDARY Muscle Function (Timed-up-and-go) |
9.76; 10.91; 8.67; 8.49; 9.01; 9.38 | <0.001 sig |
| SECONDARY Muscle Function (Gait Speed) |
0.95; 0.90; 0.98; 1.13; 1.13; 0.97 | <0.001 sig |
| SECONDARY Cardiorespiratory Fitness |
16.0; 17.7; 17.6; 19.2; 20; 17.9 | <0.001 sig |
| SECONDARY Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity |
4.2; 4.3; 4.1; 2.5; 3.1; 3.6 | 0.017 sig |
| SECONDARY Brachial Flow-mediated Dilation (FMD) |
4.6; 4.8; 5; 7.8; 6.3; 2.6 | <0.001 sig |
Summary
This study aims to investigate if protein supplementation increases 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.
Data sourced from ClinicalTrials.gov (NCT04981366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.