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OpenTrials
Completed

NCT Number: NCT02291952

Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

The goal of this application is to determine whether changing the timing of food intake prevents the adverse metabolic effects of circadian misalignment.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal schedule

Behavioral

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Change in circadian profile of plasma glucose levels

    Time frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)

    Frequent blood samples

  5. 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

  6. Change in circadian profile of plasma insulin levels

    Time frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)

    Frequent blood samples

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. Changes in sleep

    Time frame: sleep periods following day 1, days 6-7 and days 10-11

    Polysomnography

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2014
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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