Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise

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.

Study Overview

• Status: Completed
• Conditions: Aging; Sarcopenic Obesity
• Intervention / Treatment: Dietary supplement: Protein supplement; Dietary supplement: isocaloric supplement

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05508-030
    • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Fat-free Mass	Fat-free mass evaluated through dual-energy x-ray absorptiometry (DEXA) and reported as percentage	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.	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	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.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Fat-mass	Fat mass was evaluated trough dual-energy x-ray absorptiometry (DEXA) and reported as percentage.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Quadriceps Cross-sectional Area (CSA)	Quadriceps cross-sectional area (CSA) was assessed by computed tomography imaging	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.	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.	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	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	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.	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.	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)	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)	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)	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)	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)	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)	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)	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.	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.	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	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	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.	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)	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)	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.	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.	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).	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Strength - Upper Limbs	Muscle strength was evaluated using maximal dynamic strength test [1RM])	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Strength - Lower Limbs	Muscle strength was evaluated using maximal dynamic strength test [1RM])	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.	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.	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	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.	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.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid Profile (HDL)	Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Lipid Profile (LDL)	Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Lipid Profile (VLDL)	Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Lipid Profile (Triglycerides)	Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Telomere Length	Relative telomere length was measured using quantitative polymerase chain reaction (qPCR), which determines the ratio of telomeric repeat copy number (T) to a single-copy gene number (S) in a given sample. This T/S ratio is a unitless index that reflects the average telomere length relative to the reference gene. Higher T/S ratios indicate longer telomeres, while lower values indicate shorter telomeres. Although the T/S ratio does not provide absolute telomere length in base pairs, it is a widely used, validated method to assess relative telomere length in epidemiological and clinical research.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Oxidative Stress - Superoxide Dismutase	Superoxide dismutase (SOD) activity was measured using an enzyme-linked immunosorbent assay (ELISA), following the manufacturer's instructions. The assay is based on the competitive binding of SOD present in the sample and a SOD standard to a monoclonal antibody coated on a microplate.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Oxidative Stress - Catalase Activity	Catalase activity was assessed using an enzyme-linked immunosorbent assay (ELISA), according to the manufacturer's protocol. The assay quantifies catalase based on the competition between the sample catalase and a catalase standard for binding to specific antibodies coated on the microplate. The detection is achieved through a colorimetric reaction measured at a specific wavelength.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Oxidative Stress - Glutathione Peroxidase	Glutathione peroxidase activity was measured using a colorimetric assay according to the manufacturer's instructions. The method is based on the enzyme-catalyzed reduction of hydrogen peroxide by reduced glutathione (GSH), forming oxidized glutathione (GSSG). In the presence of glutathione reductase and NADPH, GSSG is converted back to GSH with concomitant oxidation of NADPH to NADP⁺.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Oxidative Stress - Glutathione Reductase	Oxidative stress markers (SOD, CAT, glutathione, GPx, GST and TBARS) were assessed through ELISA assay.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Oxidative Stress - Glutathione S-transferases	Glutathione S-transferase (GST) activity was assessed using a colorimetric assay based on the conjugation of the substrate 1-chloro-2,4-dinitrobenzene (CDNB) with reduced glutathione (GSH). The reaction results in a yellow product that is quantified by measuring the absorbance at 340 nm.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Oxidative Stress - Thiobarbituric Acid Reactive Substances	Thiobarbituric Acid Reactive Substances (TBARS): Lipid peroxidation was assessed by measuring thiobarbituric acid reactive substances (TBARS), following the manufacturer's instructions. This colorimetric assay detects malondialdehyde (MDA), a byproduct of lipid peroxidation, which reacts with thiobarbituric acid to form a colored complex measurable at 532-535 nm. Results are expressed as micromoles of MDA equivalents per liter (µmol/L), with higher values indicating greater oxidative stress.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Inflammatory Profile - IL1β	Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Inflammatory Profile - IL-10	Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Inflammatory Profile - IL-6	Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Inflammatory Profile - TNF-α	Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Inflammatory Profile - C-Reactive Protein	Inflammatory profile (i.e.; C-Reactive Protein ) was quantified via an immunoturbidimetric assay.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Area Under the Curve (AUC) of Blood Glucose	The area under the curve (AUC) of blood glucose was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the blood glucose response over the 2-hour period following glucose ingestion.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Area Under the Curve (AUC) of Insulin	The area under the curve (AUC) of insulin was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the insulin response over the 2-hour period following glucose ingestion.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Anxiety	Anxiety was assessed using the Geriatric Anxiety Inventory (GAI), a 20-item self-report questionnaire designed to measure anxiety symptoms in older adults. The total score ranges from 0 to 20, with higher scores reflecting more severe anxiety symptoms.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Depression	Depression was assessed using the Geriatric Depression Scale (GDS-15), a 15-item self-report questionnaire designed to measure depressive symptoms in older adults. The total score ranges from 0 to 15, with higher scores indicating more severe depression.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Health-related Quality of Life - Physical Component	Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Health-related Quality of Life - Mental Component	Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Sleep Quality	Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire that evaluates various aspects of sleep quality. The PSQI is scored by summing the scores of seven components, each ranging from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.	Baseline (Pre-intervention) and 16 weeks (Post-intervention)

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Hamilton Roschel, Phd, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 21, 2023
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 04234918.1.0000.0065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No