Biomarkers for Peripheral Circadian Clocks in Humans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Ghrelin
研究概览
简要总结
The purpose of this project is to improve our understanding of peripheral circadian rhythms in humans. Circadian clocks are present in most tissues of the body with importance for optimal physiological function, health, and behavior. This project will utilize simulated jetlag protocols to systematically test novel hypotheses about the regulation of peripheral circadian rhythms in humans. Specifically, we will examine how changes in the time of when we are exposed to light and the timing of when we eat impacts proteins in the blood and saliva that represent rhythms from clocks in the brain (e.g., rhythms of the hormones melatonin and cortisol coordinated by the brain) and rhythms from clocks in body tissues (e.g., proteins made by immune and bone cells, and cells in the stomach and liver). We also aim to discover new blood-based biomarkers of peripheral rhythms in humans. We anticipate our findings will be the first step in developing novel circadian based treatments for aligning peripheral clocks under conditions such as jetlag, and for developing novel circadian biomarkers that will advance our scientific understanding of circadian rhythms.
详细描述
Visit 1: Participants who meet pre-screen/initial inclusion criteria will be consented at Visit 1, complete additional questionnaires and interviews to assess inclusion/exclusion criteria, and we will collect descriptive data as well as have our clinical psychologist perform a clinical interview.
Visit 2: Participants will undergo medical screening at the Clinical Translational Research Center at the University of Colorado Boulder (UCB-CTRC) to determine health status.
Visits 3 & 6: Participants will be asked to maintain a regular ~8h sleep-wake schedule for two weeks prior to Visits 5 and 8. Participants will wear a wrist activity, skin temperature, and light exposure recorder. Participants will be asked to remain in the local time zone during ambulatory recording procedures and be asked to keep their typical schedules (e.g., not stay up all night for work or social events and not reside in a new place different from their place of residence).
Visit 4 & 7: Participants will come to the laboratory on days 11 and 39, where qualified staff will apply a Continuous Glucose Monitoring (CGM) sensor to be worn for ~3 days at home and will continue in the laboratory. For the three days leading up to the study isocaloric meals including breakfast, lunch, and dinner will be provided. Participants will be asked to consume these energy balanced research diets (no caffeine) and meal timing will be scheduled (breakfast ~30 min, lunch ~5h, and dinner ~10h after awakening,). Exercise will be proscribed for these 3-days prior to the in-lab study.
Visits 5 & 8: Participants will be randomized to condition order using an ABBA design (i.e., randomized into one of the two experimental conditions first in a crossover design: 3-days bright light exposure or 3-days of earlier timed meals). Both conditions are tested under an advanced sleep-wake schedule equivalent to traveling 5 time zones east. All participants will complete both conditions. On the second visit, participants will be tested in the other condition. Participants will live in the laboratory for 7.7 days each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1) 17-35 years old 2) English speaking 3) Healthy 5) Altitude history: Currently residing at Denver altitude or higher
排除标准
- •1. Any medical, psychiatric, or sleep disorder.
研究组 & 干预措施
Meal timing
Three days of meals, bedtimes and wake times scheduled to occur 5h earlier.
干预措施: Simulated jetlag protocol (Behavioral)
Bright light
Three days of exposure to bright light of ~3,000 lux, which is less than one-third the brightness of a sunrise or sunset (timed to start earlier by 1h each day) with scheduled bed and wake times timed 5h earlier.
干预措施: Simulated jetlag protocol (Behavioral)
结局指标
主要结局
Ghrelin
时间窗: hourly for up to 25 hours on two occasions
Appetitive hormone-promotes food intake
Leptin
时间窗: hourly for up to 25 hours on two occasions
Appetitive hormone-promotes satiety
PTH
时间窗: hourly for up to 25 hours on two occasions
Serum calcium homeostasis
CRP
时间窗: hourly for up to 25 hours on two occasions
Acute phase response/also marker of inflammation
OMD
时间窗: hourly for up to 25 hours on two occasions
Biomineralization
PYY
时间窗: hourly for up to 25 hours on two occasions
Appetitive hormone-promotes satiety
CCL18
时间窗: hourly for up to 25 hours on two occasions
Chemotaxis / immune cell trafficking
PAI-1
时间窗: hourly for up to 25 hours on two occasions
Inhibitor of fibrinolysis
IgE
时间窗: hourly for up to 25 hours on two occasions
Immune responses to parasites and allergens
次要结局
- Insulin(hourly for up to 25 hours on two occasions)
- Proteomics(hourly for up to 25 hours on two occasions)
- Glucose(continuously for up to 35 hours on two occasions)
研究者
Kenneth Wright
Professor
University of Colorado, Boulder