Circadian Dysregulation Clinical Trial
Official title:
Development of Countermeasures Against Adverse Metabolic Effects of Shift Work
Verified date | March 2020 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this application is to determine whether changing the timing of food intake prevents the adverse metabolic effects of circadian misalignment.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 29, 2018 |
Est. primary completion date | August 29, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - BMI between 18.5 and 29.9 kgm-2 - Healthy adults with regular sleep-wake timing - Non-smokers - Completion of medical and psychological screening tests - Able to spend 14 consecutive days in the sleep laboratory Exclusion Criteria: - BMI <18.5 or > 29.9 kgm-2 - History of neurological or psychiatric disorder - History of sleep disorder or regular use of sleep-promoting medication - Current prescription, herbal, or over-the-counter medication use - Traveling across 2 or more time zones within past 3 months - Donating blood within past 8 weeks - Worked night or rotating shift work within past 3 years - Hearing impairment - Drug or alcohol dependency |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in plasma leptin levels across sleep/wake cycle | Frequent blood samples | During circadian alignment (Day 7) and circadian misalignment (Day 10-11) | |
Primary | Change in circadian profile of plasma leptin | Frequent blood samples | During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13) | |
Primary | Change in glucose tolerance | Frequent blood samples before and after standardized meals | During circadian alignment (Day 7) and circadian misalignment (Day 10-11) | |
Primary | Change in circadian profile of plasma glucose levels | Frequent blood samples | During circadian alignment (Day 7) and circadian misalignment (Day 10-11) | |
Primary | Change in plasma insulin levels after standardized test meal | Frequent blood samples before and after standardized meals | During circadian alignment (Day 7) and circadian misalignment (Day 10-11) | |
Primary | Change in circadian profile of plasma insulin levels | Frequent blood samples | During circadian alignment (Day 7) and circadian misalignment (Day 10-11) | |
Secondary | o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol | Core temperature sensor throughout protocol, days 1-14. Frequent blood samples during constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13) | Core temperature and frequent blood samples | |
Secondary | Changes circadian rhythm in resting energy expenditure | Indirect calorimetry | During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13) | |
Secondary | Change in hunger and appetite, mood, and cognitive performance | Subjective hunger ratings and cognitive tests performed via computer interface | Tests taken throughout the protocol, days 1-14 | |
Secondary | Changes in microbiota, gene expression, epigenetic or proteomic markers | Frequent blood samples and saliva samples | samples taken during forced desychrony (days 7-11) and the constant routine protocols (days 3-4 and 11-13) | |
Secondary | Changes in sleep | Polysomnography | sleep periods following day 1, days 6-7 and days 10-11 |
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