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

NCT ID: NCT07030738

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ProLegumes Diet

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.

Group Type: EXPERIMENTAL

Legume-Based High-Protein Diet + Resistance Training

Intervention Type: 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.

ProMeat Diet

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.

Group Type: ACTIVE_COMPARATOR

Meat-Based High-Protein Diet + Resistance Training

Intervention Type: 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.

ProMix Diet

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.

Group Type: ACTIVE_COMPARATOR

Mixed Legume and Meat High-Protein Diet + Resistance Training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

ProLegumes; ProMeat; ProMix

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv, Israel

Countries

Israel

Facility Contacts

Assaf Buch, Professor

Role: primary

buchasaf@gmail.com

+972 54-993-1033

Other Identifiers

TLV-0540-23

Identifier Type: -

Identifier Source: org_study_id