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

Official title

Plant (Legumes) vs Animal-based (Meat) Protein Sources as an Anabolic and Metabolic-protective Options for Sarcopenic Obesity in Older Adults- A Randomized Controlled Trial

Overview

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.

Interventions

• Behavioral Legume-Based High-Protein Diet + Resistance Training
  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.
• Behavioral Meat-Based High-Protein Diet + Resistance Training
  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.
• Behavioral Mixed Legume and Meat High-Protein Diet + Resistance Training
  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.

Primary outcome measures

• MetaboAnabolic Score [Time frame: Baseline, Week 6, Week 12]

Secondary outcome measures (10)

• Functional Performance Tests (TUG, STS, Gait, Strength) [Time frame: Baseline, Week 6, Week 12]
• C-Reactive Protein (CRP) Levels [Time frame: Baseline, Week 6, Week 12]
• Lipid Profile (Triglycerides, LDL, HDL, Total Cholesterol) [Time frame: Baseline, Week 6, Week 12]
• Glycemic Control (Fasting Glucose, Insulin, HOMA-IR) [Time frame: Baseline, Week 6, Week 12]
• Resting Metabolic Rate (RMR) [Time frame: Baseline and Week 12]
• Body Composition (Lean Mass, Fat Mass, Visceral Fat Area) [Time frame: Baseline, Week 6, Week 12]
• Muscle Quality Indices (Glycogen and Intramuscular Fat Levels) [Time frame: Baseline, Week 6, Week 12]
• Ambulatory Blood Pressure (24-hour monitoring) [Time frame: Baseline, Week 6, Week 12]
• Quality of Life (SF-12) [Time frame: Baseline, Week 6, Week 12]
• Hormonal Markers (Testosterone, IGF-1, Vitamin D) [Time frame: Baseline, Week 6, Week 12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Israel · 1 center

• Tel Aviv Sourasky Medical Center — Tel Aviv

Identifiers

NCT: NCT07030738 · TLV-0540-23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗