Development of Countermeasures Against Adverse Metabolic Effects of Shift Work
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in plasma leptin levels across sleep/wake cycle
Study Overview
Brief Summary
The goal of this application is to determine whether changing the timing of food intake prevents the adverse metabolic effects of circadian misalignment.
Detailed Description
Shift work is associated with circadian misalignment and an increased risk for the development diabetes, obesity, and cardiovascular disease. This research will determine whether changing the feeding schedule can prevent metabolic alterations that can lead to the abovementioned disorders. This research will provide mechanistic insight and may provide a novel therapeutic approach against the increased risk for diabetes, obesity, and cardiovascular disease among shift workers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in plasma leptin levels across sleep/wake cycle
Time Frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples
Change in circadian profile of plasma leptin
Time Frame: During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
Frequent blood samples
Change in plasma insulin levels after standardized test meal
Time Frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples before and after standardized meals
Change in circadian profile of plasma insulin levels
Time Frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples
Change in glucose tolerance
Time Frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples before and after standardized meals
Change in circadian profile of plasma glucose levels
Time Frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples
Secondary Outcomes
- Changes circadian rhythm in resting energy expenditure(During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13))
- o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol(Core temperature and frequent blood samples)
- Changes in sleep(sleep periods following day 1, days 6-7 and days 10-11)
- Change in hunger and appetite, mood, and cognitive performance(Tests taken throughout the protocol, days 1-14)
- Changes in microbiota, gene expression, epigenetic or proteomic markers(samples taken during forced desychrony (days 7-11) and the constant routine protocols (days 3-4 and 11-13))
Investigators
Frank AJL Scheer, PhD
Frank AJL Scheer, PhD
Brigham and Women's Hospital