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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- MetaboAnabolic Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Legume-Based High-Protein Diet + Resistance Training (Behavioral)
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.
干预措施: Meat-Based High-Protein Diet + Resistance Training (Behavioral)
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.
干预措施: Mixed Legume and Meat High-Protein Diet + Resistance Training (Behavioral)
结局指标
主要结局
MetaboAnabolic Score
时间窗: Baseline, Week 6, Week 12
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.
次要结局
- 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)
- Body Composition (Lean Mass, Fat Mass, Visceral Fat Area)(Baseline, Week 6, Week 12)
- Muscle Quality Indices (Glycogen and Intramuscular Fat Levels)(Baseline, Week 6, Week 12)
- Ambulatory Blood Pressure (24-hour monitoring)(Baseline, Week 6, Week 12)
- Quality of Life (SF-12)(Baseline, Week 6, Week 12)
- Hormonal Markers (Testosterone, IGF-1, Vitamin D)(Baseline, Week 6, Week 12)