Sylvan Adams Sport Institute
Tel Aviv, 69978, Israel
NCT Number: NCT07426159
Sarcopenia, the age-related decline in muscle mass and function, is a major contributor to frailty, disability, and mortality in older adults. Current diagnostic tools assess muscle quantity or function separately and lack predictive biomarkers, limiting early detection and personalized management. This study proposes an AI-driven framework that integrates multimodal physiological, metabolic, and functional data with wearable sensor monitoring to improve sarcopenia risk assessment and guide individualized interventions.
In Phase 1, we will analyze a large retrospective dataset of 3,500 adults to identify early predictors of sarcopenia and develop a machine learning-based risk stratification model. Phase 2 will test a 12-week personalized exercise and nutrition intervention in 120 participants, using real-time sensor data and AI-guided adjustments to optimize outcomes. This integrative approach aims to advance early detection, precision intervention, and long-term muscle health in aging populations.
This study is active but is not currently recruiting participants.
50 year–70 year
All sexes
Interventional
Not applicable
Tel Aviv, 69978, Israel
Background:
Sarcopenia, defined by the progressive loss of skeletal muscle mass and function, poses significant risks for falls, disability, metabolic dysfunction, and mortality in older adults. Current clinical diagnostics rely on static measures of muscle strength or mass, often missing early-stage or subclinical decline. Moreover, conventional interventions, such as resistance training and increased protein intake, show high inter-individual variability in outcomes due to factors like baseline muscle phenotype, metabolic status, genetics, and gut microbiome composition. Emerging technologies, including wearable sensors, high-throughput metabolic profiling, and AI/ML approaches, provide an opportunity to create predictive, individualized frameworks for sarcopenia risk assessment and management.
Objectives:
Methods:
Phase 1: Retrospective analysis of multimodal data from 3,500 adults, including muscle composition (DXA, MRI), functional tests (grip strength, chair rise), metabolic markers, and microbiome profiles. AI/ML models will be trained to predict sarcopenia risk and identify key predictive features. Validation will occur using a subset of newly recruited participants under standard care.
Phase 2: A 12-week prospective intervention in 120 adults aged 50-70, stratified into sarcopenia risk groups based on Phase 1 predictions. Participants will receive AI-guided personalized exercise (resistance and aerobic) and nutrition plans, monitored via wearable sensors and a mobile app. Data collection includes MRI and DXA for muscle composition, functional performance tests, metabolic and inflammatory biomarkers, microbiome profiling, and self-reported outcomes. Intervention response will be analyzed using mixed-effects models and ML to identify predictors of efficacy.
Significance and Innovation:
This study integrates AI-driven risk prediction with personalized, real-time adaptive interventions, addressing current diagnostic and therapeutic gaps in sarcopenia care. By combining muscle structure, function, metabolic, behavioral, and microbiome data, it enables early detection of muscle decline, individualized management, and improved adherence. The framework has potential for broad clinical translation, digital health integration, and future commercialization as a scalable AI-based sarcopenia platform.
Anticipated Outcomes:
Enhanced understanding of heterogeneous responses to sarcopenia interventions.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants complete 12 weeks of supervised resistance and aerobic training combined with personalized nutrition support. Exercise prescriptions (3 resistance sessions/week; 2-3 aerobic sessions/week) and dietary guidance (including protein targets) are individualized using AI models and wearable data. A mobile app provides real-time feedback and monitoring, with biweekly safety check-ins.
Time frame: Baseline to end of follow-up (up to 12 months)
Predictive performance of an artificial intelligence-based model to identify current and future risk of sarcopenia using multimodal baseline data, including body composition, muscle function, metabolic biomarkers, and wearable-derived measures.
Time frame: Baseline to 12 weeks
Mean change in thigh skeletal muscle volume assessed by 3-Tesla MRI (Siemens Prisma) using standardized segmentation analysis.
Unit of Measure: cm³
Time frame: Baseline to 12 weeks
Mean change in maximal handgrip strength measured using a Jamar dynamometer (best of three trials).
Unit of Measure: kg
Time frame: Baseline to 12 weeks
Mean change in appendicular lean mass index (ALM divided by height squared) measured using whole-body dual-energy X-ray absorptiometry (DXA; Hologic QDR 4500A).
Unit of Measure: kg/m²
Time frame: Baseline to 12 weeks
Mean change in resting metabolic rate measured by indirect calorimetry using the Cosmed Quark RMR system under standardized fasting conditions.
Unit of Measure: kcal/day
Time frame: Baseline to 12 weeks
Mean change in gut microbiome diversity assessed using 16S rRNA gene sequencing from extracted microbial DNA and calculated using the Shannon diversity index.
Time frame: Baseline to 12 weeks
Mean change in total score of the Short Physical Performance Battery (SPPB), assessing lower extremity function.
Unit of Measure: Scale score (0-12)
Time frame: Baseline to 12 weeks
Change in health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36).
Unit of Measure: SF-36 scale score (0-100)
Tel Aviv University
Other
AI-Driven Integration of Muscle Mass and Muscle Function: A Novel Approach to Sarcopenia Risk Assessment and Intervention
Acronym: SARC-AI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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