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

NCT07030738 | Not Yet Recruiting

• 1 other identifier: TLV-0540-23
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

Plant-based diet; Red meat; Legumes; Protein intake; Anabolic diet; Resistance training; Muscle mass; Body composition; Older adults; Functional status; Sarcopenic obesity; Hypocaloric diet; Leucine; Physical function; Metabolic health; Aging population; Nutrition intervention; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 6, Week 12

Secondary Outcomes (10)

• Functional Performance Tests (TUG, STS, Gait, Strength)

  Baseline, Week 6, Week 12

• C-Reactive Protein (CRP) Levels

  Baseline, Week 6, Week 12

• Lipid Profile (Triglycerides, LDL, HDL, Total Cholesterol)

  Baseline, Week 6, Week 12

• Glycemic Control (Fasting Glucose, Insulin, HOMA-IR)

  Baseline, Week 6, Week 12

• Resting Metabolic Rate (RMR)

  Baseline and Week 12

Other Outcomes (1)

• Banked Blood and Serum for Future Biomarker and Epigenetic Analysis

  Baseline, Week 6, Week 12

Study Arms (3)

ProLegumes Diet

EXPERIMENTAL

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.

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

ProMeat Diet

ACTIVE COMPARATOR

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.

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

ProMix Diet

ACTIVE COMPARATOR

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.

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

Interventions

Legume-Based High-Protein Diet + Resistance Training 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.

Also known as: ProLegumes

ProLegumes Diet

Meat-Based High-Protein Diet + Resistance Training 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.

Also known as: ProMeat

ProMeat Diet

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

Also known as: ProMix

ProMix Diet

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv, 6423906, Israel

Location

MeSH Terms

Conditions

Obesity; Sarcopenia; Muscular Atrophy

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators, physical trainers, and outcomes assessors are blinded to group allocation. Participants and dietitians delivering the dietary intervention are not blinded, due to the nature of individualized nutrition counseling. All meals are coded neutrally to preserve blinding for trainers and assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of three parallel intervention arms: a legume-based high-protein hypocaloric diet (ProLegumes), a meat-based high-protein hypocaloric diet (ProMeat), or a mixed-source high-protein hypocaloric diet (ProMix). Each group follows their assigned intervention for the 12-week study period.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-05

Locations

IL (1)