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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• MetaboAnabolic Score [Срок оценки: Baseline, Week 6, Week 12]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Tel Aviv Sourasky Medical Center — Tel Aviv

Идентификаторы

NCT: NCT07030738 · TLV-0540-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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