Lifestyle Intervention to Improve Muscle Function in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
The goal of this randomized controlled two-arm trial is to determine the effect of a diet and exercise intervention for 12 weeks on body composition, muscle function, and energy balance in 80 adults aged 50 years and over with obesity and insulin resistance. The main questions the trial aims to answer are: Will 12 weeks of a structured nutrition plan + exercise reduce fat mass, improve muscle function, and increase energy deficit compared to the usual diet + exercise. The hypothesis is that 12 weeks of a structured nutrition plan + exercise will reduce fat mass, improve muscle function, and produce greater energy deficit than the usual diet + exercise. Participants will be provided with all meals for 12 weeks and will exercise at the Center under supervision three times each week. Pre and post-intervention, body composition, physical function, and energy deficit will be measured.
详细描述
In the United States nearly one third of adults over 60 years of age have sarcopenic obesity which encompasses the combined effect of muscle impairment and obesity. A strategy that addresses the combined effect of muscle impairment and obesity while modulating muscle mass and composition is an unanswered challenge. This 12-week study will evaluate the effects of a structured nutrition plan combined with an exercise program on body fat and muscle mass, lower-extremity function (Short Physical Performance Battery), muscle strength (handgrip and knee strength), and daily caloric intake. The study will enroll adults aged 50 years and older with obesity (body mass index ≥ 30 kg/m²) and insulin resistance as indicated by a homeostasis model assessment of insulin resistance (HOMA-IR) score ≥ 3. Subjects will be randomly allocated to receive the structured nutrition plan and exercise intervention or to their usual diet and exercise in equal numbers (40 per group). The study will enrich our understanding of the physiological adaptations necessary for effective lifestyle interventions to improve muscle function.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 50 years.
- •Body mass index (BMI) ≥ 30 kg/m
- •Homeostatic model assessment of insulin resistance ≥
- •Mini-Mental State Examination (MMSE) >
- •Geriatric Depression Scale-15 (GDS-15) <
- •Sedentary (less than 90 minutes/week of moderate to vigorous activity).
- •Ability to provide written informed consent.
排除标准
- •Diagnosis of cancer (received within five years) or diabetes (type 1 and 2), or significant musculoskeletal, or cardiovascular, or hepatic, or renal, disease or dysfunction.
- •Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal laboratory markers.
- •Fluctuation in body weight > 3 kg in the preceding two months
- •Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.
研究组 & 干预措施
Structured nutrition plan + exercise
Intervention: Participants receive a structured nutrition plan, and exercise under supervision.
干预措施: Supervised Exercise (Behavioral)
Typical or usual diet + exercise
Participants receive a typical or usual diet, and exercise under supervision
干预措施: Typical or usual diet (Behavioral)
Typical or usual diet + exercise
Participants receive a typical or usual diet, and exercise under supervision
干预措施: Supervised Exercise (Behavioral)
Structured nutrition plan + exercise
Intervention: Participants receive a structured nutrition plan, and exercise under supervision.
干预措施: Structured nutrition plan (Behavioral)
研究者
Candida Rebello
Assistant Professor
Pennington Biomedical Research Center