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

N/ANot Yet RecruitingNCT07030738

Tel-Aviv Sourasky Medical Center180 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Sarcopenic Obesity Obesity and Obesity-related Medical Conditions Obesity (Body Mass Index >30 kg/m2)

Interventions

Legume-Based High-Protein Diet + Resistance TrainingBEHAVIORAL

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.

Meat-Based High-Protein Diet + Resistance TrainingBEHAVIORAL

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.

Mixed Legume and Meat High-Protein Diet + Resistance TrainingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.