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

Not Applicable

Not yet recruiting

• Conditions: Sarcopenic Obesity; Obesity and Obesity-related Medical Conditions; Obesity (Body Mass Index >30 kg/m2); Sarcopenia; Muscle Loss; Aging

• Registration Number: NCT07030738
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Study Start: 2025-09-01
• Primary Completion: 2026-03
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Aged 55 years or older.
• Diagnosed with obesity.
• At risk for sarcopenia, based on at least one of the following: Low score on the validated SARC-F-calf questionnaire (as suggested in prior studies). More than one comorbidity associated with sarcopenic obesity (e.g., diabetes, osteoporosis, cardiovascular disease, etc.). Polypharmacy: taking 8 or more prescribed medications. Evidence of strength or functional impairment, assessed using validated measurements at the baseline visit.

Exclusion Criteria

• Recent use of steroid agents within the past 6 months (replacement therapy is allowed).
• Uncorrected hypothyroidism: TSH > 6 mIU/L.
• Diagnosis of malignancy within the past 5 years, except for non-melanoma skin cancer.
• Chronic kidney disease (CKD) at stage >1 (due to protein restriction needs).
• Recent (≤6 months) or unstable cardiovascular condition, or NYHA Class III or higher congestive heart failure.
• Currently performing resistance training.
• Currently undergoing nutritional therapy, have recently changed diet (<1 month), or are enrolled in active weight-loss programs or therapies (including lifestyle and/or pharmacotherapy). Note: Patients stable on GLP-1 agonists or other pharmacotherapy are eligible.
• Vegetarians/vegans, or individuals with aversion or allergy to all legumes or all red meat products.
• Habitual consumption of more than 3 servings/week of either legumes or red meat.
• Other medical, psychiatric conditions, or lab abnormalities that may pose a risk to participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MetaboAnabolic Score	Baseline, Week 6, Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Functional Performance Tests (TUG, STS, Gait, Strength)	Baseline, Week 6, Week 12	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
C-Reactive Protein (CRP) Levels	Baseline, Week 6, Week 12	High-sensitivity CRP will be measured via blood samples to assess systemic inflammation. CRP is a biomarker associated with metabolic and cardiovascular risk.
Lipid Profile (Triglycerides, LDL, HDL, Total Cholesterol)	Baseline, Week 6, Week 12	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.
Glycemic Control (Fasting Glucose, Insulin, HOMA-IR)	Baseline, Week 6, Week 12	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.
Resting Metabolic Rate (RMR)	Baseline and Week 12	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.
Body Composition (Lean Mass, Fat Mass, Visceral Fat Area)	Baseline, Week 6, Week 12	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.
Muscle Quality Indices (Glycogen and Intramuscular Fat Levels)	Baseline, Week 6, Week 12	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.
Ambulatory Blood Pressure (24-hour monitoring)	Baseline, Week 6, Week 12	Blood pressure will be monitored over 24 hours using a validated automatic ambulatory device to capture daily fluctuations.
Quality of Life (SF-12)	Baseline, Week 6, Week 12	Health-related quality of life assessed using the validated SF-12 questionnaire, translated and culturally adapted to Hebrew.
Hormonal Markers (Testosterone, IGF-1, Vitamin D)	Baseline, Week 6, Week 12	Serum levels of testosterone (bioavailable and free), IGF-1, and 25-hydroxyvitamin D will be measured using standard clinical protocols.

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel