Optimizing Circadian Rhythms by Regulating Eating Patterns to Reduce Cardiometabolic Disease Risk Among Firefighters--The Healthy Heroes Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Assess the feasibility and adherence of TRE
研究概览
简要总结
This is the first study of its kind to assess and test an intervention to improve biological rhythms and general health of shift workers, specifically first responders with San Diego Fire and Rescue. In a randomized control trial, investigators intend to measure the health impact of Time Restricted Eating in emergency responders who work a 24-hour shift schedule.
详细描述
Participants will be randomly assigned to a control group of behavioral nutrition counseling (standard of care) or the intervention group of standard of care with the addition of adopting a 10 hour eating window for one year (TRE). For the first 3 months of intervention, participants will be monitored closely by the research team. For the following 9 months, participants will be in a self-monitored intervention period. Investigators will evaluate the impact of TRE on blood glucose levels, biomarkers, sleep/mood, and weight loss. These assessments will be made at baseline, at the end of the 12-week monitored intervention period, and every 3 months (months 6, 9, and 12) during the self-monitored intervention period for one year. Food/drink intake, activity, and sleep will be monitored with the smartphone myCircadianClock application ("mCC app") throughout the study. A continuous glucose monitor, a wrist-worn actigraphy device, and questionnaires will also be used during the study.
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
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Firefighter or work a 24-hr shift schedule with San Diego Fire and Rescue
- •Age: 21-65 years
- •Own a smartphone (Apple or Android Operating System)
- •If participants are on cardiovascular medications (HMG-CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs), no dose adjustments will be allowed during the study period
排除标准
- •Insulin-dependent diabetes mellitus
- •Presence of acute chronic inflammatory or autoimmune disease (defined by acute symptoms or C-reactive protein >10 mg/L), malabsorption syndromes, liver disease, or kidney disease (stage 3 or greater)
- •Uncontrolled thyroid disease
- •Intake of drugs likely to interfere with study endpoints, including corticosteroids, anabolic steroids, anti-psychotics, antiretroviral drugs, and immunosuppressive drugs (within 3 months of starting the study)
- •Presence or recent history of anemia (hematocrit <33% within 3 months of starting the study)
- •History of bariatric surgery
- •Pregnant or breast-feeding women
- •Current or recent (within 12 months of starting the study) pregnancy or breastfeeding, or intention of becoming pregnant in the next 6 months
- •Any cancer other than non-melanoma skin cancer in the last 3 years
- •On a special or prescribed diet for other reasons (e.g. Celiac disease)
- •Depression determined by the Beck Depression Inventory (BDI)
- •Planned international travel during study period
- •Insufficient logging on the mCC app (does not log at least 2 entries a day for 10 of 14 days) during baseline will exclude from being randomized into the intervention period
结局指标
主要结局
Assess the feasibility and adherence of TRE
时间窗: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Measured by percentage of days logged that participants ate within their 10-hour window and by end of study responses. Note: Significant changes expected in participants in the TRE arm of the study on and off shift. No significant changes expected in the standard of care arm of the study. Primary endpoint analysis will be done by comparing baseline and 12-week intervention.
Evaluate the impact of TRE on glucose homeostasis at end of intervention compared to baseline
时间窗: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Measured by an ambulatory continuous glucose monitoring device and blood work throughout the study. Note: Significant changes expected in participants who had elevated glucose homeostasis at baseline. No significant changes expected in those within normal ranges at baseline. Primary endpoint analysis will be done by comparing baseline and 12-week intervention.
次要结局
- Assess changes in metabolic biomarkers in response to TRE at end of intervention compared to baseline(Timeframe: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year)
- Systolic blood pressure (mmHg) in response to TRE at end of intervention compared to baseline(Timeframe: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year)
- Diastolic blood pressure (mmHg) in response to TRE at end of intervention compared to baseline(primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year)
- Body weight (kg)(primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year)
研究者
Pam Taub, MD
Associate Professor of Medicine
University of California, San Diego