Clinical trial NCT02291952: Development of Countermeasures Against Adverse Metabolic Effects of Shift Work
Official title: Development of Countermeasures Against Adverse Metabolic Effects of Shift Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circadian Dysregulation
Keywords: Circadian Misalignment, Forced Desynchrony, Metabolism, Meal-timing, Circadian
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-11-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in plasma leptin levels across sleep/wake cycle
timeFrame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
measure: Change in circadian profile of plasma leptin
timeFrame: During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
measure: Change in glucose tolerance
timeFrame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
measure: Change in circadian profile of plasma glucose levels
timeFrame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
measure: Change in plasma insulin levels after standardized test meal
timeFrame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
measure: Change in circadian profile of plasma insulin levels
timeFrame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Secondary outcomes:
measure: o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol
timeFrame: Core temperature and frequent blood samples
measure: Changes circadian rhythm in resting energy expenditure
timeFrame: During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
measure: Change in hunger and appetite, mood, and cognitive performance
timeFrame: Tests taken throughout the protocol, days 1-14
measure: Changes in microbiota, gene expression, epigenetic or proteomic markers
timeFrame: samples taken during forced desychrony (days 7-11) and the constant routine protocols (days 3-4 and 11-13)
measure: Changes in sleep
timeFrame: sleep periods following day 1, days 6-7 and days 10-11
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Frank A Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chellappa SL, Engen PA, Naqib A, Qian J, Vujovic N, Rahman N, Green SJ, Garaulet M, Keshavarzian A, Scheer FAJL. Proof-of-principle demonstration of endogenous circadian system and circadian misalignment effects on human oral microbiota. FASEB J. 2022 Jan;36(1):e22043. doi: 10.1096/fj.202101153R.