Clinical Trial: Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

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 Summary: 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.
Sponsor: Brigham and Women's Hospital

Current Primary Outcome:

  • 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 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol [ Time Frame: 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)
  • Changes circadian rhythm in resting energy expenditure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: sleep periods following day 1, days 6-7 and days 10-11 ]
    Polysomnography


Original Secondary Outcome: Same as current

Information By: Brigham and Women's Hospital

Dates:
Date Received: November 12, 2014
Date Started: November 2014
Date Completion: March 2018
Last Updated: December 8, 2016
Last Verified: December 2016