Sarcopenic Obesity

16

Review clinical trials related to Sarcopenic Obesity. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Effect of Combined Resisted Training and Protein-based Diet on Frailty in Sarcopenic Elderly Women

Sixty obese elderly women will be recruited from Fawkia hospital outpatient clinic diagnosed by sarcopenia and randomly allocated into two groups for a 12-week intervention. Patients will be divided into 2 groups (A and B): * Group A (combined intervention group: n=30): will perform supervised resistance exercise training three times per week and follow a high-protein diet (1.3 g protein/kg/day) * Group B (control group: n=30): will receive a high-protein diet and general health advices and be asked to maintain their usual lifestyle. They will be offered the intervention post-study.

Participants needed: 60
Trial details
Age: 60-70Biological sex: FemaleType: InterventionalSponsor: Cairo UniversityUpdated: Jun 4, 2026Locations: 1
Eligibility criteria

1) Female gender 2) Age 60-70 years 3) BMI ≥ 30 kg/m2 4) Sarcopenic patients dia...

1) Sever cardiovascular, pulmonary, renal, or hepatic disease. 2) Uncontrolled d...

Status: Recruiting

GLP-1R Actions on Muscle and the Skeleton

The GRAMS study objectives are to assess the musculoskeletal changes that occur after weight loss using GLP-1 based therapy. A lifestyle intervention with diet and exercise is included to assess any mitigating effects are provided, versus a control group with regular exercise and diet.

Participants needed: 50
Trial details
Phase: Phase 4Age: 18-50Biological sex: AllType: InterventionalSponsor: Pennington Biomedical Research CenterUpdated: May 29, 2026Locations: 1
Eligibility criteria

Subjects will have a BMI between 30kg/m2 [+8]

Menopausal females. [+17]

Status: Recruiting

Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults

Obesity is a significant health problem whose prevalence has tripled worldwide in the last fifty years, also involving older people. Older people present sarcopenia, characterized by the progressive loss of muscle mass and strength. Sarcopenia, accompanied by an increase in adipose tissue, causes a specific condition called sarcopenic obesity. The increase in adipose tissue and the decrease in muscle mass determines a reduction in strength and physical abilities necessary to perform everyday activities of daily living in obese older people. To understand how the condition of excess adipose tissue influences the activities of daily living of older people with obesity, it is necessary to compare the physical abilities, body composition, and results of various motor skills with normal-weight subjects, corrected for sex and age.

Participants needed: 160
Trial details
Age: 65+Biological sex: AllType: ObservationalSponsor: Istituto Auxologico ItalianoUpdated: May 29, 2026Locations: 1
Eligibility criteria

Both sexes [+3]

Absence of signed informed consent [+5]

Status: Not yet recruiting

CT Body Composition as Predictor of Exercise Therapy Outcome in Peripheral Arterial Disease

Supervised exercise therapy (SET) is the recommended first treatment for patients with leg artery disease (peripheral arterial disease, PAD) causing pain when walking. However, approximately 40% of patients do not benefit meaningfully and go on to require a procedure to open the blocked arteries within three months. This study investigates whether body composition measurements - specifically the quality of muscle and the amount of belly fat - taken from a CT scan already performed as part of routine care, can identify before treatment begins which patients are unlikely to respond to exercise therapy. If confirmed, this approach would allow doctors to use information from a scan patients are already having, with no additional tests, to better match patients to the right treatment from the start.

Participants needed: 128
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Nemocnice AGEL Trinec-Podlesi a.s.Updated: Feb 25, 2026
Eligibility criteria

Age 18 years or older [+5]

Fontaine stage III or IV peripheral arterial disease (rest pain or tissue loss;... [+5]

Status: Recruiting

Adverse Outcomes and Mortality in Liver Transplant

Prospective natural history pilot study to explore the link between muscle composition using an MRI-based Muscle Assessment Score (MAsS) and adverse outcomes in liver transplant candidates.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Mayo ClinicUpdated: Aug 15, 2025Locations: 1
Eligibility criteria

All patients with end-stage liver disease undergoing evaluation for liver transp... [+2]

Status: Recruiting

Dissecting the Molecular and Cellular Pathophysiology of Sarcopenic Obesity in the Elderly

Ageing is characterised by a change in body composition with a parallel decrease in muscle mass and an increase and central redistribution of fat. When drastically exacerbated, these two processes culminate in a condition known as sarcopenic obesity (SO). SO is characterised by the coexistence of obesity and sarcopenia (i.e. reduced muscle mass and function) and is a growing public health problem in the elderly. The health risks of obesity and sarcopenia act synergistically, maximising the risk of disability of OS. The molecular mechanisms underlying OS are largely unknown. Increased fat mass induces chronic systemic inflammation and alters the profiles of adipokines and hormones, promoting the development of sarcopenia. On the other hand, the reduction in muscle tissue (SM) typical of sarcopenia is characterised by an alteration in the metabolic properties of skeletal muscle with an increase in insulin resistance and a reduction in energy expenditure that favours the accumulation and dysfunction of adipose tissue (AT). The cellular alterations that would seem to underlie OS are: altered autophagy, cellular senescence, epigenetic and mitochondrial alterations and maladaptive activation of intra- and intercellular inflammatory circuits (e.g. cytokines, extracellular vesicles, dysfunctional circulating leukocytes). However, the interconnections between these mechanisms are still unclear. The impact of OS can be dramatic on the health and quality of life of those affected. Therefore, the identification of early biomarkers that can recognise overweight and obese individuals at risk of developing SO is of paramount importance. This would shed light on the heterogeneity of an otherwise homogeneous clinical condition, opening new horizons towards the conscious design of more personalised therapeutic strategies, allowing a more rational use of the limited resources available for the growing elderly population. The study design designed to achieve this aim is a cross-sectional observational study with an additional multicentre procedure lasting two years.

Participants needed: 1,108
Trial details
Age: 65-99Biological sex: AllType: ObservationalSponsor: IRCCS San RaffaeleUpdated: Jun 18, 2025Locations: 1
Eligibility criteria

patients who are candidates for hip surgery [+2]

unavailability to participate in the study [+3]

Status: Not yet recruiting

Plant vs Animal-based Protein Sources as an Anabolic and Metabolic-protective Options for SO in Older Adults

This study is testing how different types of protein - from red meat, legumes (like lentils and beans), or a mix of both - affect muscle strength, body composition, and metabolic health in older adults with obesity who are also at risk for sarcopenia (loss of muscle mass and function). Participants will follow a personalized weight loss diet with one high-protein meal each day that includes either red meat, legumes, or both, along with a home-based strength training program. The study will last three months and will include health assessments such as blood tests, muscle and fat measurements, and physical function tests. The goal is to find out which type of protein source is most helpful for improving strength, reducing body fat, and supporting healthy aging.

Participants needed: 180
Trial details
Age: 55+Biological sex: AllType: InterventionalSponsor: Tel-Aviv Sourasky Medical CenterUpdated: Jun 22, 2025Locations: 1
Eligibility criteria

Aged 55 years or older. [+2]

Recent use of steroid agents within the past 6 months (replacement therapy is al... [+9]

Status: Recruiting

Pilot Study of the Human Metagenome in Metabolic Diseases

This is a cohort study to understand the role of the human metagenome, and associated metabolites, in health and in various diseased states, in particular obesity as well as sarcopenia. Recruited participants will have their fecal, salivary, urine, serum, and in certain instances, mucosal samples taken, for metagenomic sequencing and metabolite testing. We hope to uncover various differences and signatures in the metagenome and metabolome in various diseased states, with potential future therapeutic applications in personalised medicine.

Participants needed: 600
Trial details
Age: 21-99Biological sex: AllType: ObservationalSponsor: Sengkang General HospitalUpdated: May 15, 2025Locations: 1
Eligibility criteria

Obese (BMI>27.5kg/m2) [+1]

No informed consent [+1]

Status: Not yet recruiting

Dietary Modification Intervention Involving Family Support (FamNUTRI) for Managing Sarcopenic Obesity Among Community-dwelling Older Adults

The goal of this pilot RCT is to examine the feasibility and preliminary effects of a dietary modification intervention involving family support (FamNUTRI) on the management of sarcopenic obesity among older people living in the community. The main questions it aims to answer are: 1. Is the intervention feasible and acceptable for community-dwelling older people with sarcopenic obesity? 2. What are the preliminary effects of the intervention on managing sarcopenic obesity in this population? Researchers will compare the FamNUTRI group, the NUTRI group, and a passive control group to see if the dietary modification intervention with family support has additional benefits over the dietary modification intervention alone and no intervention. Participants will: Attend 6 face-to-face one-hour bi-weekly sessions over 15 weeks Receive bi-weekly phone calls to foster adherence to the hypocaloric diet with high protein intake (For the FamNUTRI group) Invite a family member to attend the sessions together

Participants needed: 72
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: The Hong Kong Polytechnic UniversityUpdated: Apr 18, 2025Locations: 1
Eligibility criteria

older adults aged 65 years old or above who are living in the community and have... [+3]

having any existing disease or condition that affects digestion or food intake,... [+4]

Status: Recruiting

Feasibility and Effectiveness of Eccentric Exercise in Sarcopenic Older Adults with Heart Failure: a Pilot Study

This study is designed to evaluate the safety, feasibility, and effectiveness of a 12-week eccentric exercise program for older adults with sarcopenia (muscle loss) or sarcopenic obesity and chronic heart failure (HF). The program aims to improve physical performance, muscle strength, and overall health without causing excessive strain on participants. Eccentric exercise has shown potential benefits for improving muscle function, and this study will help determine if it is a safe and effective option for individuals with heart failure and muscle loss. Study Goals: The primary aim of this study is to test the feasibility and effectiveness of an eccentric exercise program for older adults with sarcopenia and CHF. The study will monitor physical performance, adherence to the program, and participants' ability to tolerate the exercise, as well as any impact on heart and muscle health. Study Population: A screening visit will be scheduled to determine if individuals meet the criteria to participate in the study. During this visit, a detailed assessment will be made, and if eligible, participants will sign an informed consent form. This study will assess whether a 12-week eccentric exercise program can help improve muscle strength, cardiovascular health, and overall physical performance in individuals with HF and sarcopenia. The program will involve exercising on an eccentric bike, which is designed to reduce strain on the heart while providing effective muscle strengthening benefits. The study will use several physical performance tests to assess the impact of the exercise program, including: 1. Short Physical Performance Battery (SPPB): Evaluates mobility and strength. 2. 6-Minute Walk Test (6MWT): Measures cardiovascular fitness. 3. Handgrip Strength and Leg Strength Tests: Assess upper and lower body muscle strength. 4. Additionally, body composition will be evaluated using tools such as DXA scans and bioelectrical impedance analysis (BIA) to measure muscle mass, fat, and overall health status. The program's adherence and tolerance will be carefully monitored by measuring session completion, intensity, and participant feedback. Primary Outcomes Feasibility Measures: 1. Recruitment and Completion Rate: The ratio of participants recruited to those who successfully complete the study, including post-intervention assessments. 2. Session Attendance: The number of training sessions attended out of the total planned sessions. 3. Adherence to Training Volume: The number of prescribed exercises completed by participants compared to the total planned. 4. Program Tolerance: Evaluated by comparing the Rate of Perceived Exertion (RPE) during sessions to the target RPE. To be considered feasible, the study must meet these criteria: Recruitment \>50%, Follow-up loss \<20%, Median attendance at training sessions \>80%, Median adherence to prescribed volume \>75%, Tolerance to RPE \>70%. Secondary Outcomes Effectiveness Measures: 1. SARC-F: A tool for identifying individuals at risk of sarcopenia, based on self-reported issues like weakness and difficulty walking. 2. Mini Nutritional Assessment (MNA): Evaluates nutritional status to rule out malnutrition, which could affect training outcomes. 3. Mini Mental State Examination (MMSE): Assesses cognitive function. 4. Minnesota Living with Heart Failure Questionnaire: Evaluates how heart failure affects daily life. 5. International Physical Activity Questionnaire (IPAQ): Measures physical activity levels at baseline. In addition to the physical performance tests mentioned, the study will assess muscle mass and fat distribution using DXA scans and BIA, providing a comprehensive view of body composition. Finally, the feasibility of remotely monitoring patients' physical activity to determine the impact of the intervention on their daily lives, specifically in terms of mobility and autonomy is assessed. To this end, patients will be asked to wear a set of five sensors (two on the ankles, two on the wrists, and one on the waist) for at least four days. The Axivity AX6 sensors, chosen for their light weight and long battery life, will collect data used to monitor time spent moving, sitting, and lying down, as well as to assess the quality of the recorded movements.

Participants needed: 15
Trial details
Age: 65-85Biological sex: AllType: InterventionalSponsor: Universita di VeronaUpdated: Mar 14, 2025Locations: 2
Eligibility criteria

Age 65 to 85 years [+15]

Severe obstructive heart disease [+7]

Status: Recruiting

Effects of the EatWelLog App on Diet Management for Older Adults With Sarcopenic Obesity

Sarcopenic obesity, characterised by concurrent reduced muscle mass and excess body fat, affects 11% of older adults worldwide, rising to 23% in those over 75. Considering the negative synergistic impact on health, promoting muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies for managing SO. Exercise and nutrition are the primary interventions recommended for SO. This project aims to evaluate the effects of the EatWellLog App developed by the investigators' team for local older adults, in improving: * their sarcopenic obesity status, measured by all four diagnostic criteria, including grip strength, muscle mass, physical performance and body fat mass (primary outcome), and, * nutritional self-efficacy, nutritional status, dietary quality, health-related quality of life, and adherence to diet and exercise regimens (secondary outcomes), by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group. The EatWellLog App, designed for older adults with SO, incorporating Klasnja and Pratt's five-strategy framework for mobile health (mHealth) applications development to facilitate health behavioural change. This App supports users with SO in managing daily diets that promote gradual weight loss and muscle mass preservation, adhering to the dietary regimen for this population. Forty older adults with SO will be recruited from local community health centres and then randomized to either m-health or control groups. Both groups will receive an 8-week supervised programme separately. The programme consists of personalised dietary modification programme and group-based exercise training which have been tested and used in the investigators' pilot and General Research Fund (GRF) project. Additionally, only the m-health group will be instructed to use the App for daily diet self-management. Participants will be assessed on a variety of outcomes immediately after the 8-week supervised programme (T1), which will be compared to the baseline (T0). To explore the possible long-term effects of the intervention, other measurements will be conducted at 3-(T2) and 6-(T3) months after the supervised programme, which will be compared with those conducted at T0.

Participants needed: 40
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: The Hong Kong Polytechnic UniversityUpdated: Feb 13, 2025Locations: 1
Eligibility criteria

Aged 65 or above, and living in the community; [+4]

Individuals with diseases impacting digestion or food consumption, including sev... [+3]

Status: Recruiting

Prevalence of Sarcopenic Obesity in COPD

The goal of this observational study is to the purpose is to apply of ESPEN/EASO criteria for the diagnosis of sarcopenic obesity and calculation of OS prevalence in a sample of COPD patients. In addition, this study want to evaluate the impact of sarcopenic obesity on the respiratory function of COPD patients and the degree of severity of respiratory disease, assessed by spirometric examination; diaphragm thickness and excursion, by ultrasonographic study; performance, assessed by six-minute walk test (6-MWT); quality of life and degree of dyspnea (mMRC, Barthel dyspnea, S. George Respiratory Questionnaire); compliance and outcomes at the end of the respiratory rehabilitation course. Comparison with normal-weight patients with and without sarcopenia will help to better understand the clinical impact of sarcopenic obesity in this category of patients.

Participants needed: 236
Trial details
Age: 40-100Biological sex: AllType: ObservationalSponsor: IRCCS San Raffaele RomaUpdated: Feb 12, 2025Locations: 1
Eligibility criteria

Patients aged > 40 years of either sex; [+3]

COPD not stabilized at the time of enrollment; [+13]

Status: Recruiting

Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

The proposed research project aims to investigate sarcopenic obesity (SO), a condition characterized by the combination of high body fat and low skeletal muscle mass, with a focus on muscle function. SO has been defined according to the ESPEN-EASO algorithm, and this study aims to evaluate its validity, exploring associations with circulating biomarkers and functional outcomes. By enrolling 75 subjects with SO and a control sample of 75 subjects with non-sarcopenic obesity, the primary objective of this study is to examine the consistency of the proposed diagnostic criteria with respect to circulating biomarkers and functional outcomes. Secondary objectives include the assessment of additional variables and the detailed profiling of SO subjects through questionnaires and multidimensional tests. The ethical aspect of the present study will be guaranteed through written informed consent and protection of privacy, respecting international regulatory standards. The investigators believe that this work provides significant contributions to the understanding of sarcopenic obesity and to the validation of diagnostic criteria, with possible implications for public health. The investigators are available for further clarifications and approvals required by the Ethics Committee.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Elisa GiannettaUpdated: Feb 10, 2025Locations: 1Duration: 24 Months
Eligibility criteria

BMI equal more than 30 [+1]

any disease or medication that can significantly affect body composition (eg.mal... [+5]

Status: Not yet recruiting

Comparative Analysis of Sarcopenia in Rehabilitation Outcomes Following Femoral Neck Fracture: a Study in Normal Weight and Obese Study Cohort

Impact of Obesity on Sarcopenia Prevalence and Severity in Elderly Adults Recovering from Femoral Neck Fractures: A Prospective Study Introduction Age-related muscle loss, or sarcopenia, which includes reductions in both muscle mass and function, is increasingly recognized as a critical health issue in the elderly. Sarcopenia is associated with frailty, disability, and increased mortality. With its rising prevalence, obesity further complicates aging, leading to a condition termed "sarcopenic obesity" (SO), where sarcopenia coexists with obesity. This combination amplifies risks for physical disability, falls, and fractures in older adults. Although sarcopenia and obesity individually contribute to adverse health outcomes, their combined impact on recovery from hip fractures, particularly femoral neck fractures, is under-researched. Hip fractures severely impact the elderly, with over 40% failing to regain pre-fracture functionality and a mortality rate above 35% within three years post-fracture. This study aims to assess the impact of obesity on sarcopenia prevalence and severity in older adults recovering from femoral neck fractures, addressing an essential gap in understanding SO's role in post-fracture rehabilitation outcomes. Objectives * To evaluate the prevalence and severity of sarcopenia among normal-weight versus obese elderly adults post-femoral neck fracture. * To investigate the association between sarcopenic obesity and functional recovery. * To determine whether obesity modifies sarcopenia's impact on rehabilitation outcomes. Risk-Benefit Statement The study entails minimal risk, as all procedures are non-invasive and consistent with routine rehabilitation practices. The potential benefits include enhanced understanding of sarcopenia's effect on hip fracture recovery, which may inform improved rehabilitation practices. Comprehensive health assessments may also benefit participants' post-fracture care. Study Design Overview This prospective observational study includes hospitalized elderly patients undergoing rehabilitation post-femoral neck fracture. After obtaining informed consent, participants will complete an initial assessment, including demographic information, medical history, cognitive status, and anthropometric measurements. Blood samples will be collected for biochemical markers. Stratification and Assessment: Patients will be categorized into normal-weight and obese groups. Comprehensive assessments, including cognitive function, mobility, frailty, muscle strength, and nutritional status, will establish a baseline for studying sarcopenia and obesity's impact on rehabilitation outcomes. Population and Criteria: Sample Size: Up to 300 participants Inclusion Criteria: * Age 60-85 * Recent femoral neck fracture (within the past year) * Ability to provide informed consent Exclusion Criteria: * Inability to comply with study requirements * History of neurodegenerative or psychiatric conditions, recent major surgeries (excluding femoral neck fracture), or conditions affecting muscle metabolism Procedures: Baseline Evaluation: * Cognitive Function: Mini-Mental State Examination (MMSE) * Anthropometric Measurements: BMI from height and weight * Functional Independence (FIM): Level of independence in daily activities * Mobility (Up \& Go Test): Indicator of balance and mobility * Frailty and Muscle Strength: Handgrip strength, SARC-F questionnaire, Muscle Strength and Reflex Assessment (MSRA) * Nutritional Status: Mini Nutritional Assessment (MNA) * Laboratory Tests: CRP, calcium, vitamin D, CBC Post-Rehabilitation Evaluation: After rehabilitation, participants will repeat baseline assessments to determine changes in sarcopenia severity and functional status. Unscheduled Visits: Participants may request evaluations outside the scheduled timeline, documented by the investigator as necessary. Statistical Analysis * Descriptive Analysis: Mean and standard deviations for continuous data, frequencies for categorical data. * Comparative Analysis: Independent t-tests to compare normal-weight and obese groups, dependent t-tests for within-group changes. * Univariate Analysis: Chi-square or Fisher's exact tests with a significance level of P \< 0.05. Ethics and Confidentiality This study will adhere to the Declaration of Helsinki, ICH-GCP guidelines, and applicable regulations. Informed consent will be obtained from all participants, and confidentiality measures will protect patient privacy, with data limited to authorized personnel and anonymized in reports. Institutional Review Board (IRB) Approval IRB approval will be obtained from the Israeli Ministry of Health, following ICH-GCP guidelines. The IRB will oversee the study protocol, consent forms, and all participant materials. Data Storage and Study Termination Data will be securely stored, with

Participants needed: 300
Trial details
Age: 60+Biological sex: AllType: ObservationalSponsor: Shmuel Harofeh Hospital, Geriatric Medical CenterUpdated: Nov 26, 2024
Eligibility criteria

Age between 60-85 [+2]

Inability to comply with the study protocol or understand and sign an informed c... [+6]

Status: Not yet recruiting

Feasibility of At-Home Chair-Based Resistance Band Training to Improve Balance, Strength, and Bone Density in Older Adults

The purpose of this study is to determine the feasibility of implementing a 24-week at-home chair-based resistance band training intervention, to determine effectiveness of a the a 24-week at-home chair-based resistance band training intervention in improving body composition and to determine the effectiveness of a 24-week at-home chair-based resistance band training intervention in improving physical performance in adults 50 years and older, receiving care at the UT Physicians Center for Healthy Aging.

Participants needed: 40
Trial details
Age: 50+Biological sex: AllType: InterventionalSponsor: The University of Texas Health Science Center, HoustonUpdated: Nov 4, 2024Locations: 1
Eligibility criteria

English-speaking [+1]

inability to provide informed consent on their own [+2]

Status: Not yet recruiting

The Effect of Sarcopenic Obesity on Sleep in Individuals With Obesity Hypoventilation Syndrome

Obesity Hypoventilation Syndrome(OHS) is characterized by daytime hypercapnia and sleep-disordered breathing without other causes of hypoventilation in individuals with a body mass index above 30 kg/m2. It is stated that obesity is at the basis of the metabolic changes seen in individuals diagnosed with OHS. Also sedentary lifestyle habits, which are common in obese individuals, cause the risk of sarcopenia due to loss of muscle strength and mass, accumulation of adipose tissue in the body, and decreased exercise capacity. Reduced exercise capacity due to obesity has been shown in the literature to strongly interact with mortality risk. As a result of obesity and all this negative picture, impaired emotional state and decreased quality of life are observed in individuals. Simultaneously, sleep parameters are also negatively affected. In particular, increased adipose tissue leads to loss of muscle mass and strength, increased risk of sarcopenia and sleep-related problems. The association of obesity and sarcopenia is referred to as 'sarcopenic obesity'. Sarcopenic obesity is defined as the coexistence of sarcopenia and obesity. The concept of sarcopenic obesity has recently taken its place in the literature. In particular, there are very few studies on its relationship with sleep parameters. However, while obesity is the basis of OHS, there are no studies on the presence and effects of sarcopenic obesity in this patient group. Based on this point, we aim to investigate the effects of sarcopenic obesity on sleep parameters, exercise capacity and quality of life in individuals with OHS.

Participants needed: 64
Trial details
Age: 50+Biological sex: AllType: ObservationalSponsor: Istanbul UniversityUpdated: Aug 13, 2024Locations: 1
Eligibility criteria

>50 years old [+2]

Patient who have immobilized for more than 15 days in the last 6 months [+3]