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

Tel Aviv Sourasky Medical Center

Status: Begins enrollment in 1 month

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

Treatments: Behavioral: Meat-Based High-Protein Diet + Resistance Training; Behavioral: Mixed Legume and Meat High-Protein Diet + Resistance Training; Behavioral: Legume-Based High-Protein Diet + Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07030738

TLV-0540-23

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

ProLegumes Diet

Experimental group

Description:

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.

Treatment:

Behavioral: Legume-Based High-Protein Diet + Resistance Training

ProMeat Diet

Active Comparator group

Description:

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.

Treatment:

Behavioral: Meat-Based High-Protein Diet + Resistance Training

ProMix Diet

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mixed Legume and Meat High-Protein Diet + Resistance Training