Long-term Effects of Weight Loss and Supplemental Protein on Physical Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- Change in Expanded Short Physical Performance Battery Score
研究概览
简要总结
This study will evaluate the effects of diet composition (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and 12-months of follow-up on physical function, muscle mass, and weight loss maintenance in obese older adults. Participants will receive either a protein or carbohydrate supplement along with a behavioral weight loss intervention.
详细描述
The study will use a 3-group design in 225 obese (BMI 27-45 kg/m2), older (65-85 years) men and women at risk for disability (eSPPB <2.5) who will undergo a 6-month weight loss intervention followed by a 12-month follow-up phase to test the overall hypothesis that a higher protein (1.2 g/kg body wt/d) / lower carbohydrate (CHO) diet during a 6-month weight loss intervention improves physical function compared with an isocaloric lower protein (the current Recommended Dietary Allowance (RDA), 0.8 g/kg body wt/d) / higher CHO diet, and whether continuing a higher protein / lower CHO diet for 12-months following weight loss will result in better maintenance of improved physical function. All participants will undergo a 6-month weight loss intervention involving caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt). Physical function (primary aim) will be assessed by the expanded Short Physical Performance Battery (primary outcome) and lower extremity muscle strength at baseline, 6-, 12- and 18-months. Weight loss maintenance and body composition (secondary aim) will be assessed by dual-energy X-ray absorptiometry (DXA) and computed tomography (CT) at baseline, 6- and 18-months. Bone mineral density (DXA) and cardiometabolic risk factors will also be measured at baseline, 6- and 18-months.
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65-85 years
- •BMI: 27-45 kg/m2
- •No regular resistance training and/or aerobic exercise (>20 mins/d) for past 6 months
- •eSPPB <2.5
- •No contraindications for safe and optimal participation in exercise training
- •Approved for participation by Medical Director (Dr. Lyles)
- •Willing to provide informed consent
- •Agree to all study procedures and assessments
- •Willing to consume protein/CHO supplements for up to 18 months
- •Able to provide own transportation to study visits and intervention sessions
排除标准
- •Weight loss (≥5%) in past 6 months
- •Dependent on cane or walker
- •Cognitive impairment (MoCA score <22)
- •Severe arthritis, or other musculoskeletal disorder
- •Joint replacement or other orthopedic surgery in past 6 months
- •Uncontrolled resting hypertension (>160/90 mmHg);
- •Insulin-dependent or uncontrolled diabetes (HbA1c ≥8%)
- •Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen; uncontrolled endocrine/metabolic disease; neurological or hematological disease; cancer requiring treatment in past year, except non-melanoma skin cancers; liver or renal disease; or clinically evident edema
- •Unstable, severe depression
- •Serious conduction disorder, uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm at rest or ≥2 mm with exercise)
- •Abnormal kidney function (eGFR <30 based on serum creatinine, age, gender, and race)
- •Anemia (Hb<13 g/dL in men; <12 g/dL in women)
- •Drug abuse or excessive alcohol use (>7 drinks/week women; >14 drinks/week men)
- •Use of any tobacco or nicotine products in the past year
- •Osteoporosis (T-score < -2.5 on hip or spine scan)
- •Regular use of growth/steroid hormones, sex steroids or corticosteroids, osteoporosis medication, or protein supplements
- •Weight loss medications or procedures
- •Current participation in another intervention study
结局指标
主要结局
Change in Expanded Short Physical Performance Battery Score
时间窗: 18 months
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in lower extremity physical function assessed by the expanded Short Physical Performance Battery score over 18 months. The expanded Short Physical Performance Battery score ranges from 0 to 4 with higher scores indicating better lower extremity physical function
次要结局
- Intermuscular Adipose Tissue(18 months)
- Lower Extremity Muscle Strength(18 months)
- Weight Change(18 months)
- Thigh Muscle Volume(18 months)
- Total Body Lean Mass(18 months)
- Total Body Fat Mass(18 months)