Sarcopenic ObesityNCT04981366
Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise
A study testing Protein supplement and isocaloric supplement in people with Sarcopenic Obesity and Aging, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study aims to investigate if protein supplementation increases the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenic Obesity, Aging
- What is being tested?
- Protein supplement and isocaloric supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2021to 25 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years and older;
- Body mass index (BMI) > 30 kg/m2;
- Sarcopenia;
- not engage into exercise training programas.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Protein Supplementation Associated With Exercise Training in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction
This study aims to investigate if protein supplementation increases the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.
Read the detailed description
Protocol amendment and primary outcomes:
In August 2021, during participant recruitment and before treatment-group unblinding, database lock, and any unblinded between-group analyses, an amendment to the study protocol and Statistical Analysis Plan was approved by the Institutional Review Board/Ethics Committee (CAAE 04234918.1.0000.0065, version 4). The amendment specified four primary lean-mass outcomes: total fat-free mass (TFFM), appendicular fat-free mass (AFFM), appendicular fat-free mass adjusted for body mass index (AFFM/BMI), and leg fat-free mass (LFFM). The Statistical Analysis Plan also prespecified the use of Hochberg's procedure to control the family-wise type I error rate across these four co-primary outcomes.
The structured Primary Outcome Measures section of the ClinicalTrials.gov record was subsequently updated on May 28, 2025. This update reflects the outcome framework specified in the August 2021 protocol amendment and Statistical Analysis Plan.
- Conditions
- Sarcopenic Obesity, Aging
- Being tested
- Protein supplement, isocaloric supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementDietary supplement
40g of whey protein in the breakfast;
isocaloric supplementDietary supplement
42g of isocaloric supplement in the breakfast;
| Study group | Role | What they receive |
|---|---|---|
| Control group (CTRL) | No intervention | Patients allocated to this arm will not receive any intervention. |
| Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN) | Experimental | Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus protein supplementation. Receives: Dietary Supplement: Protein supplement |
| Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA) | Placebo comparator | Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus isocaloric placebo. Receives: Dietary Supplement: isocaloric supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Fat-free Mass
Fat-free mass evaluated through dual-energy x-ray absorptiometry (DEXA) and reported as percentage
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Appendicular Fat-free Mass
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.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Appendicular Fat-free Mass to Body Mass Index Ratio
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
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Leg Fat-free Mass
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.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Secondary outcomes (34)
Fat-mass
Fat mass was evaluated trough dual-energy x-ray absorptiometry (DEXA) and reported as percentage.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Quadriceps Cross-sectional Area (CSA)
Quadriceps cross-sectional area (CSA) was assessed by computed tomography imaging
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Rectus Femoris Cross-sectional Area (CSA)
Rectus femoris cross-sectional area (CSA) was assessed by B-mode ultrasound.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Vastus Lateralis Cross-sectional Area (CSA)
Vastus lateralis cross-sectional area (CSA) was assessed by B-mode ultrasound.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Fiber Cross-sectional Area (fCSA)- Type I
Muscle fiber cross-sectional area (type I) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Fiber Cross-sectional Area (fCSA)- Type II
Muscle fiber cross-sectional area (type II) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I)
Bone turnover was assessed by an automated electrochemiluminescence method.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP)
Bone turnover was assessed by an automated electrochemiluminescence method.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Mineral Density (Whole-body)
bone mineral density (whole-body) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Mineral Density (Femur Neck)
bone mineral density (femur neck) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Mineral Density (Total Hip)
bone mineral density (total hip) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Mineral Density (Lumbar Spine)
bone mineral density (lumbar spine) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Total Volumetric Density)
Bone microarchitecture (total volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Trabecular Volumetric Density)
Bone microarchitecture (trabecular volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Cortical Volumetric Density)
Bone microarchitecture (cortical volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (BV/TV)
Bone microarchitecture (BV/TV) was assessed at the distal region of the radius of the non-dominant limb using high-resolution peripheral quantitative computed tomography (HR-pQCT). Specifically, trabecular bone volume fraction (BV/TV) is computed as the ratio of the trabecular bone mineral density (Tb.vBMD in mg HA/cm3) and 1200 mg HA/cm3, which is assumed to be the density of fully mineralized bone. Afterwards, the values were multiplied by 100 to reflect the percentage of trabecular bone volume fraction.
Measured: 16 weeks
Bone Microarchitecture (Trabecular Number - Tb. N)
The trabecular number (Tb.N) was analyzed using the ridge extraction technique in high-resolution peripheral quantitative computed tomography (HR-pQCT). In this approach, the trabeculae were treated as elongated structures resembling ridges. The technique involves detecting the central axis (ridge) of each trabecular element in a 3D image.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Trabecular Separation)
Trabecular separation (Tb.Sp), represents the average distance between trabeculae in the trabecular bone region. It was assessed using the distance transformation method, applied to the background (void space) of the trabecular structure. The transformation method measures the distance from each voxel (3D pixel) in the void space to the nearest trabecular element, and the average of these distances is then calculated. This method enables precise quantification of trabecular spacing in high-resolution 3D images.
The separation is inversely related to trabecular density, as closer trabeculae indicate a higher bone volume fraction (BV/TV) and a denser bone network. The calculation of trabecular separation can be expressed as:
Tb.Sp = 1- BV/TV : Tb.N
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Trabecular Thickness)
Trabecular thickness (Tb.Th) represents the average thickness of trabecular bone elements. It was assessed by calculating the mean thickness of the segmented trabecular structure, using the distance transformation method applied to the trabecular bone tissue.
The trabecular thickness is calculated as a ratio of the bone volume fraction (BV/TV) to trabecular number (Tb.N): Tb.Th =BV/TV : Tb.N
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Cortical Porosity)
Cortical porosity (Ct.Po) is quantified using a density-based approach that segments bone into three compartments: compact cortex, transitional zone, and trabecular compartment. Voxels with a density below 1000 mg HA/cm³ indicate the presence of void space (pores), and porosity is estimated as the ratio of void space in each voxel. The mean of this ratio is calculated across all voxels in the compartment of interest, and the values were multiplied by 100. This method captures pores with diameters below the scanner's spatial resolution but relies on the assumption of fixed bone tissue mineral density and may be susceptible to image noise and beam hardening.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Cortical Thickness)
Bone microarchitecture (cortical thickness) wwas assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Cortical Pore Diameter)
Bone microarchitecture (cortical pore diameter) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Stiffness)
Stiffness (kN/mm) is defined as the total reaction force of the model divided by the applied displacement. It represents the resistance of a material or structure to deformation under an applied load. A higher stiffness value indicates greater resistance to deformation, while a lower value suggests more flexibility.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Estimated Failure Load)
Estimated failure load is indirectly calculated from linear finite element (FE) models using a yield criterion. The failure load is estimated when a specified volume of bone tissue (critical volume) exceeds a critical strain threshold, at which point the model is assumed to have yielded. This approach is often based on the Pistoia criterion, which is used to predict the point of failure in the material based on its mechanical properties and deformation behavior.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Isometric Muscle Strength - Handgrip
Isometric muscle strength was evaluated using a handgrip dynamometer (Jamar®, Sammons Preston Rolyan, USA).
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Strength - Upper Limbs
Muscle strength was evaluated using maximal dynamic strength test [1RM])
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Strength - Lower Limbs
Muscle strength was evaluated using maximal dynamic strength test [1RM])
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Function (Short Physical Performance Battery)
Muscle function evaluated through battery of tests - Short Physical Performance Battery (SPPB). The SPPB is a standardized assessment of lower extremity function that includes three components: balance tests, gait speed over 4 meters, and the five-times sit-to-stand test. Each component is scored from 0 to 4, with a total score ranging from 0 to 12. Higher scores indicate better physical performance. The SPPB is widely used to evaluate physical function, predict disability, and monitor health status in older adults.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Function (30-s Sit-to-stand Test)
The 30-second sit-to-stand test is a simple measure of lower body strength and functional capacity. Participants are asked to rise from a seated position and sit back down as many times as possible within 30 seconds. The total number of complete sit-to-stand repetitions performed in the given time is recorded. This test is commonly used to assess physical fitness and mobility, particularly in older adults or individuals with health conditions.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Function (Timed-up-and-go)
The Timed Up and Go (TUG) test is a simple and widely used assessment of mobility and balance. Participants are asked to stand up from a seated position, walk 3 meters, turn around, walk back to the chair, and sit down again, all as quickly as possible. The total time taken to complete the task is recorded. The TUG test is commonly used to evaluate functional mobility, fall risk, and the ability to perform daily activities, particularly in older adults or individuals with mobility impairments.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Function (Gait Speed)
Muscle function evaluated through 4-m gait speed test. The 4-meter usual gait speed test measures the time it takes for a participant to walk a distance of 4 meters at their usual pace. The test is commonly used to assess walking speed, which is an important indicator of mobility, physical function, and overall health. The time taken to complete the 4-meter walk is recorded and used to evaluate the individual's functional capacity, with slower times potentially indicating mobility impairments or a higher risk of adverse health outcomes.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Cardiorespiratory Fitness
Cardiorespiratory fitness was evaluated by maximal oxygen uptake (VO²max) during a maximal exercise test on a treadmill
Measured: 16 weeks
Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a method used to estimate insulin resistance based on fasting plasma glucose and fasting insulin levels. It is calculated using the following formula:
HOMA-IR = (fasting insulin [µU/mL] × fasting glucose [mg/dL]) / 405. Higher values of HOMA-IR indicate greater insulin resistance and are considered worse. There is no fixed theoretical maximum value, but typical reference ranges in healthy individuals are usually <2. Values above this threshold may suggest impaired insulin sensitivity or metabolic dysfunction. The HOMA-IR is widely used in clinical and research settings as a surrogate marker for insulin resistance.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Brachial Flow-mediated Dilation (FMD)
Brachial flow-mediated dilation (FMD) is a non-invasive measure of endothelial function, assessed using high-resolution B-mode ultrasound. The test evaluates the percent change in brachial artery diameter in response to increased blood flow (reactive hyperemia) following 3 minutes of cuff occlusion, on the forearm. An increase in arterial diameter after cuff release indicates vasodilation mediated by nitric oxide. Higher FMD values reflect better endothelial function, whereas lower values are associated with cardiovascular risk and impaired vascular health.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Aug 2021
- Primary completion21 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamilton Augusto Roschel da Silva, University of Sao Paulo General Hospital
- Investigators
- Hamilton Roschel, Phd, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981366
- Sponsor's protocol ID
- 04234918.1.0000.0065
- Status last verified
- May 2025
- First submitted
- 1 Jul 2021
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Protein Supplementation Associated With Exercise Training in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction
- ClinicalTrials.gov ID
- NCT04981366
- Acronym / sponsor ID
- 04234918.1.0000.0065
- Conditions
- Sarcopenic Obesity, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Protocol amendment and primary outcomes:
In August 2021, during participant recruitment and before treatment-group unblinding, database lock, and any unblinded between-group analyses, an amendment to the study protocol and Statistical Analysis Plan was approved by the Institutional Review Board/Ethics Committee (CAAE 04234918.1.0000.0065, version 4). The amendment specified four primary lean-mass outcomes: total fat-free mass (TFFM), appendicular fat-free mass (AFFM), appendicular fat-free mass adjusted for body mass index (AFFM/BMI), and leg fat-free mass (LFFM). The Statistical Analysis Plan also prespecified the use of Hochberg's procedure to control the family-wise type I error rate across these four co-primary outcomes.
The structured Primary Outcome Measures section of the ClinicalTrials.gov record was subsequently updated on May 28, 2025. This update reflects the outcome framework specified in the August 2021 protocol amendment and Statistical Analysis Plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group (CTRL) | No intervention | –Patients allocated to this arm will not receive any intervention. |
| Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN) | Experimental | Dietary Supplement: Protein supplementPatients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus protein supplementation. |
| Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA) | Placebo comparator | Dietary Supplement: isocaloric supplementPatients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus isocaloric placebo. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 years and older;
- Body mass index (BMI) > 30 kg/m2;
- Sarcopenia;
- not engage into exercise training programas.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein supplement40g of whey protein in the breakfast; | Dietary supplement | Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN) |
| isocaloric supplement42g of isocaloric supplement in the breakfast; | Dietary supplement | Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA) |
Primary outcome
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.
34 secondary outcomes
Fat-mass
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Quadriceps Cross-sectional Area (CSA)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Rectus Femoris Cross-sectional Area (CSA)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Vastus Lateralis Cross-sectional Area (CSA)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Fiber Cross-sectional Area (fCSA)- Type I
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Fiber Cross-sectional Area (fCSA)- Type II
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Mineral Density (Whole-body)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Mineral Density (Femur Neck)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Mineral Density (Total Hip)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Mineral Density (Lumbar Spine)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Total Volumetric Density)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Trabecular Volumetric Density)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Cortical Volumetric Density)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (BV/TV)
Time frame: 16 weeks
Bone Microarchitecture (Trabecular Number - Tb. N)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Trabecular Separation)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Trabecular Thickness)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Cortical Porosity)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Cortical Thickness)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Cortical Pore Diameter)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Stiffness)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Bone Microarchitecture (Estimated Failure Load)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Isometric Muscle Strength - Handgrip
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Strength - Upper Limbs
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Strength - Lower Limbs
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Function (Short Physical Performance Battery)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Function (30-s Sit-to-stand Test)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Function (Timed-up-and-go)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Function (Gait Speed)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Cardiorespiratory Fitness
Time frame: 16 weeks
Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Brachial Flow-mediated Dilation (FMD)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamilton Roschel, Phd principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplement and isocaloric supplement in people with Sarcopenic Obesity and Aging, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Fat-free Mass (time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.