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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProLegumes Diet | Experimental | Participants in this arm will follow a hypocaloric, high-protein diet primarily based on legumes as the main protein source. The diet aims to improve sarcopenic obesity outcomes over a 3-month intervention period, combined with home-based resistance training. |
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| ProMeat Diet | Active Comparator | Participants in this arm will follow a hypocaloric, high-protein diet primarily based on meat as the main protein source. This diet also aims to improve sarcopenic obesity outcomes over 3 months with the same exercise regimen. |
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| ProMix Diet | Active Comparator | Participants in this arm will follow a hypocaloric, high-protein diet that includes a combination of both legumes and meat as protein sources. The intervention period and exercise program are identical to the other arms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Legume-Based High-Protein Diet + Resistance Training | Behavioral | Participants receive a hypocaloric, high-protein diet primarily based on legumes (e.g., lentils, beans, peas) designed to meet protein goals (~2g/kg body weight). Diet is combined with a structured home-based resistance training program performed 3 times per week for 12 weeks. The exercise includes progressive resistance exercises focusing on major muscle groups using body weight and resistance bands. |
| Measure | Description | Time Frame |
|---|---|---|
| MetaboAnabolic Score | The MetaboAnabolic Score is a composite outcome designed to assess the intervention's efficacy in addressing sarcopenic obesity from both metabolic and functional perspectives. The score includes 10 variables: five metabolic (body fat percentage, intramuscular adipose tissue [IMAT], visceral fat area, blood pressure, and triglyceride or LDL levels) and five functional (leg muscle/lean mass, leg and arm strength, Timed Up and Go [TUG], and 2-minute walk test). A clinically meaningful threshold is defined for each variable based on scientific literature or expected changes from the hypocaloric intervention. One point is awarded for each variable that meets or exceeds the threshold, resulting in a total score ranging from 0 to 10. A higher score reflects greater overall improvement. | Baseline, Week 6, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Performance Tests (TUG, STS, Gait, Strength) | TUG, 2-minute walk, 30s sit-to-stand, one-leg stand (gait, endurance, stability). Muscle strength of upper and lower limbs measured via handheld dynamometers. Gait variability and balance measured using Mobility Lab (OPAL) sensors | Baseline, Week 6, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Banked Blood and Serum for Future Biomarker and Epigenetic Analysis | Frozen plasma and blood samples will be collected and stored at -20 °C and - 80 °C respectively for future testing of myokines, adipokines, and epigenetic markers. | Baseline, Week 6, Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv | Tel Aviv | 6423906 | Israel |
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Participants will be randomly assigned to one of three parallel intervention arms: a legume-based high-protein hypocaloric diet (ProLegumes), a meat-based high-protein hypocaloric diet (ProMeat), or a mixed-source high-protein hypocaloric diet (ProMix). Each group follows their assigned intervention for the 12-week study period.
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Investigators, physical trainers, and outcomes assessors are blinded to group allocation. Participants and dietitians delivering the dietary intervention are not blinded, due to the nature of individualized nutrition counseling. All meals are coded neutrally to preserve blinding for trainers and assessors.
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| Meat-Based High-Protein Diet + Resistance Training | Behavioral | Participants follow a hypocaloric, high-protein diet emphasizing animal-based protein sources, mainly lean meats, to achieve ~2g/kg body weight protein intake. This dietary intervention is combined with a 12-week, home-based resistance training protocol, performed thrice weekly, targeting major muscle groups with progressive overload using body weight and resistance bands. |
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| Mixed Legume and Meat High-Protein Diet + Resistance Training | Behavioral | Participants adhere to a hypocaloric, high-protein diet combining both legumes and lean meats as protein sources to reach ~2g/kg body weight. The dietary plan is paired with a 12-week home-based resistance training program, performed 3 times per week, emphasizing progressive resistance exercises for all major muscle groups using body weight and resistance bands. |
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| C-Reactive Protein (CRP) Levels |
High-sensitivity CRP will be measured via blood samples to assess systemic inflammation. CRP is a biomarker associated with metabolic and cardiovascular risk. |
| Baseline, Week 6, Week 12 |
| Lipid Profile (Triglycerides, LDL, HDL, Total Cholesterol) | Fasting blood samples will be used to assess lipid parameters including triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and total cholesterol. These are key indicators of cardiovascular and metabolic health. Changes will be compared between intervention groups. | Baseline, Week 6, Week 12 |
| Glycemic Control (Fasting Glucose, Insulin, HOMA-IR) | Fasting glucose and insulin levels will be used to evaluate glycemic control and insulin sensitivity. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) will be calculated. | Baseline, Week 6, Week 12 |
| Resting Metabolic Rate (RMR) | RMR will be measured via indirect calorimetry under standardized fasting and resting conditions. It reflects basal energy expenditure and can indicate metabolic adaptation or dysfunction. Changes will be analyzed in the context of body composition shifts. | Baseline and Week 12 |
| Body Composition (Lean Mass, Fat Mass, Visceral Fat Area) | Dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis will be used to assess lean body mass, total fat mass, and visceral fat area. Changes in these components will provide insight into the impact of the dietary interventions on sarcopenic obesity. | Baseline, Week 6, Week 12 |
| Muscle Quality Indices (Glycogen and Intramuscular Fat Levels) | Quantitative ultrasound will assess skeletal muscle glycogen storage and intramuscular fat infiltration (IMAT). This will be assessed by ultrasound of rectus femoris with MuscleSound® software, which analyzes cross-sectional area, thickness, and composition. These indices serve as biomarkers of muscle health and metabolic quality, with changes reflecting diet and exercise response. | Baseline, Week 6, Week 12 |
| Ambulatory Blood Pressure (24-hour monitoring) | Blood pressure will be monitored over 24 hours using a validated automatic ambulatory device to capture daily fluctuations. | Baseline, Week 6, Week 12 |
| Quality of Life (SF-12) | Health-related quality of life assessed using the validated SF-12 questionnaire, translated and culturally adapted to Hebrew. | Baseline, Week 6, Week 12 |
| Hormonal Markers (Testosterone, IGF-1, Vitamin D) | Serum levels of testosterone (bioavailable and free), IGF-1, and 25-hydroxyvitamin D will be measured using standard clinical protocols. | Baseline, Week 6, Week 12 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D055948 | Sarcopenia |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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