Circadian Dysregulation
Conditions
Keywords
Circadian Misalignment, Forced Desynchrony, Metabolism, Meal-timing, Circadian
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.
Interventions
BEHAVIORALMeal schedule
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in circadian profile of plasma insulin levels | During circadian alignment (Day 7) and circadian misalignment (Day 10-11) | Frequent blood samples |
| Change in plasma leptin levels across sleep/wake cycle | During circadian alignment (Day 7) and circadian misalignment (Day 10-11) | Frequent blood samples |
| Change in circadian profile of plasma leptin | During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13) | Frequent blood samples |
| Change in glucose tolerance | 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 | During circadian alignment (Day 7) and circadian misalignment (Day 10-11) | Frequent blood samples |
| Change in plasma insulin levels after standardized test meal | During circadian alignment (Day 7) and circadian misalignment (Day 10-11) | Frequent blood samples before and after standardized meals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Indirect calorimetry |
| Change in hunger and appetite, mood, and cognitive performance | Tests taken throughout the protocol, days 1-14 | Subjective hunger ratings and cognitive tests performed via computer interface |
| 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) | Frequent blood samples and saliva samples |
| Changes in sleep | sleep periods following day 1, days 6-7 and days 10-11 | Polysomnography |
| o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol | Core temperature and frequent blood samples | 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) |
Countries
United States
Outcome results
None listed