Sedentary Behavior Interrupted: A Randomized Crossover Trial of Acute Effects on Biomarkers of Healthy Aging in the Laboratory (Project 1)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Postprandial glucose
研究概览
简要总结
This protocol "Sedentary Behavior Interrupted: A randomized crossover trial of acute effects on biomarkers of healthy aging in the laboratory (Project 1)" is part of a National Institutes of Aging Program Grant called "Sedentary Time & Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 1 of the STAR program) is a 3-condition randomized crossover clinical trial of up to 86 postmenopausal women to test whether different interruptions to prolonged sitting improve metabolism.
详细描述
The specific aims of this protocol include:
Aim 1. To investigate the acute effect of sitting interruption modalities on postprandial glucose and insulin concentrations, compared to prolonged sitting.
Aim 2. To investigate the acute effect of sitting interruption modalities on the physiologic parameters of endothelial function, compared to prolong sitting.
Aim 3. To explore the moderating effect of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •55 years of age and above
- •any ethnicity or race
- •screened to sit for 8 or more hours per day, perform less than 60 sit-to-stand transitions per day & engage in less than 20 minutes of moderate-to-vigorous physical activity (MVPA) per day
- •BMI 25 - 45 kg/m2
- •ambulatory
- •medically stable without any health conditions that would inhibit standing or PA;
- •able to give informed consent & comply with study protocols;
- •able to read, communicate, and write fluently in English;
- •able to travel to study visits;
- •no menstruation for at least one year;
- •not participating or not planning to participate in a physical activity or weight loss program or research study.
排除标准
- •Mental state that would preclude complete understanding of the protocol or compliance;
- •type 1 diabetes;
- •type 2 diabetes using insulin or with poor glycemic control (greater than 10% for all participants);
- •poorly controlled hypertension (Systolic Blood Pressure ≥165 or Diastolic Blood Pressure ≥100);
- •chronic illness that may be associated with weight change (HIV/AIDS, active cancer, or uncontrolled thyroid disease),
- •anemia (hemoglobin ≤11g/dL);
- •personal or first-degree relative history of venous thrombosis;
- •weight instability in past 3 months (no more than 5% up or down);
- •regular use of vasodilator medication and high risk of stroke and/or heart attack (i.e., history of multiple hospitalizations (>2X) in the last 6 months), congestive heart failure, atrial fibrillation, and/or stroke;
- •regular use of immunosuppressant or corticosteroid medication;
- •blood donation less than 56 days prior to screening visit,
- •smoking cigarettes or smoking or ingesting anything, and other use of tobacco products including e-cigarettes.
- •diagnosis of orthostatic hypotension
研究组 & 干预措施
Control Condition (Protocol A)
Following a one-hour sitting run-in period, participants will sit for a 5-hour period including a mid-point bathroom break.
Frequent Sit-to-Stands (Protocol B)
Following a 1-hour sitting run-in period, participants will sit for a 5-hour period including a 2-min stand every 15 min throughout the 5-hr protocol period and a mid-point bathroom break.
干预措施: Frequent sit-to-stands (Behavioral)
Stand More (Protocol C)
Following a 1-hour sitting run-in period, participants will sit for a 5-hour period including 5 8-minute standing breaks, 1 per hour, and a mid-point bathroom break.
干预措施: Stand More (Behavioral)
结局指标
主要结局
Postprandial glucose
时间窗: 5 hours
To investigate the acute effect of sitting interruption modalities on postprandial glucose compared to prolonged sitting.
Insulin
时间窗: 5 hours
To investigate the acute effect of sitting interruption modalities on insulin concentrations compared to prolonged sitting.
次要结局
- Flow mediated dilation(5 hours)
- Blood pressure(5 hours)
研究者
Dorothy Sears
Associate Professor
University of California, San Diego