The Effect of Protein Supplementation and Resistance Training on Body Composition, Functional Parameters, Metabolic Adaptation, and Nitrogen Balance in Adults (Aged ≥45 Years) With Overweight/Obesity Receiving Incretin-Based Weight Loss Medication for 6 Months: A Multicenter RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Change in Fat Mass (kg)
研究概览
简要总结
This study aim to evaluate the effects of protein supplements and resistance training on body composition, functional parameters, metabolic adaptation, and nitrogen balance in adults (aged ≥45 years) with overweight/obesity receiving weekly Incretin-Based obesity management medication treatment for 6 months.
A parallel design, open-label, multicenter randomized controlled trial will be conducted among 240 patients (aged ≥45 years) initiating Incretin-Based obesity management medication. Participants will be recruited through obesity clinics at the Tel-Aviv Sourasky Medical Center and the Tel-Aviv Assuta Medical Center, obesity clinics of HMOs, and social media groups. They will be randomly assigned to one of two groups in a 1:1 ratio: protein supplements ('Easy Whey' 25 gr protein/day) plus weekly resistance training and no intervention. Data will be collected at baseline, 3, and 6 months, including demographics, medical status, body composition, functional parameters, resting metabolic rate, nitrogen balance, and physical activity performance.
All participants will be advised to follow an exercise regime, a reduced-calorie diet based on the principle of the Mediterranean eating pattern and be encouraged to follow a regular meeting schedule with a registered dietitian.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥45 years.
- •Overweight or obese (BMI ≥30, or BMI ≥27 with at least one obesity-related comorbidity).
- •Eligible to receive incretin-based weight loss medications (e.g. Wegovy or Mounjaro).
- •Able to read and speak Hebrew fluently.
排除标准
- •Medical contraindications for incretin-based weight-loss medications.
- •Current treatment with insulin or sulfonylurea medications.
- •Inflammatory bowel disease.
- •Active or unstable psychiatric disorders or cognitive impairment.
- •Active bulimia nervosa.
- •Previous bariatric surgery or bariatric endoscopic procedures.
- •Use of other weight management medications within the past month.
- •Weight loss of ≥5% within the past three months.
- •Implanted cardiac pacemaker or other electronic implants.
- •Regular resistance training within the past three months.
- •Regular use of protein supplements.
- •Allergy or intolerance to dairy proteins or vegan lifestyle.
结局指标
主要结局
Change in Fat Mass (kg)
时间窗: Baseline, 3 months, 6 months.
Change in fat mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis
Change in Fat Mass Percentage (%)
时间窗: Baseline, 3 months, 6 months.
Change in fat mass percentage (%) as measured by InBody 770 bioelectrical impedance analysis
Change in Lean Body Mass (kg)
时间窗: Baseline, 3 months, 6 months.
Change in lean body mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.
Change in Skeletal Muscle Mass (kg)
时间窗: Baseline, 3 months, 6 months.
Change in skeletal muscle mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.
Change in Body Mass Index (BMI)
时间窗: Baseline, 3 months, 6 months.
hange in Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²), based on body weight measured by InBody 770.
次要结局
- Change in Resting Metabolic Rate(Baseline, 3 months, 6 months.)
- Change in Nitrogen Balance(Baseline, 3 months, 6 months.)
- Change in Short Physical Performance Battery (SPPB) score(Baseline, 3 months, 6 months.)
- Change in Sit-to-Stand Test Performance(Baseline, 3 months, 6 months.)
- Change in Handgrip Strength(Baseline, 3 months, 6 months.)
- Change in Nutrient Intake Based on 3-Day Food Diaries(Baseline, 3 months, 6 months.)
- Change in Mediterranean Diet Adherence(Baseline, 3 months, 6 months.)
- Change in Eating Behavior - Control of Eating Questionnaire (CoEQ)(Baseline, 3 months, 6 months.)
- Change in Food Reward Sensitivity - Power of Food Scale (PFS)(Baseline, 3 months, 6 months.)
研究者
Shiri Sherf Dagan
Dietitian and Epidemiologist
Assuta Medical Center