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Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

Primary Purpose

Circadian Dysregulation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal schedule
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Circadian Dysregulation focused on measuring Circadian Misalignment, Forced Desynchrony, Metabolism, Meal-timing, Circadian

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

During Forced Desynchrony sleep and wake will occur at different circadian phases, while meals are restricted to the biological day.

During Forced Desynchrony sleep and wake, as well as meals, will occur at different circadian phases.

Outcomes

Primary Outcome Measures

Change in plasma leptin levels across sleep/wake cycle
Frequent blood samples
Change in circadian profile of plasma leptin
Frequent blood samples
Change in glucose tolerance
Frequent blood samples before and after standardized meals
Change in circadian profile of plasma glucose levels
Frequent blood samples
Change in plasma insulin levels after standardized test meal
Frequent blood samples before and after standardized meals
Change in circadian profile of plasma insulin levels
Frequent blood samples

Secondary Outcome Measures

o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol
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
Indirect calorimetry
Change in hunger and appetite, mood, and cognitive performance
Subjective hunger ratings and cognitive tests performed via computer interface
Changes in microbiota, gene expression, epigenetic or proteomic markers
Frequent blood samples and saliva samples
Changes in sleep
Polysomnography

Full Information

First Posted
November 12, 2014
Last Updated
March 18, 2020
Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02291952
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 19, 2015 (Actual)
Primary Completion Date
August 29, 2018 (Actual)
Study Completion Date
August 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circadian Dysregulation
Keywords
Circadian Misalignment, Forced Desynchrony, Metabolism, Meal-timing, Circadian

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
During Forced Desynchrony sleep and wake will occur at different circadian phases, while meals are restricted to the biological day.
Arm Title
Control
Arm Type
Other
Arm Description
During Forced Desynchrony sleep and wake, as well as meals, will occur at different circadian phases.
Intervention Type
Behavioral
Intervention Name(s)
Meal schedule
Primary Outcome Measure Information:
Title
Change in plasma leptin levels across sleep/wake cycle
Description
Frequent blood samples
Time Frame
During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Title
Change in circadian profile of plasma leptin
Description
Frequent blood samples
Time Frame
During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
Title
Change in glucose tolerance
Description
Frequent blood samples before and after standardized meals
Time Frame
During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Title
Change in circadian profile of plasma glucose levels
Description
Frequent blood samples
Time Frame
During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Title
Change in plasma insulin levels after standardized test meal
Description
Frequent blood samples before and after standardized meals
Time Frame
During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Title
Change in circadian profile of plasma insulin levels
Description
Frequent blood samples
Time Frame
During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Secondary Outcome Measure Information:
Title
o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol
Description
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)
Time Frame
Core temperature and frequent blood samples
Title
Changes circadian rhythm in resting energy expenditure
Description
Indirect calorimetry
Time Frame
During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
Title
Change in hunger and appetite, mood, and cognitive performance
Description
Subjective hunger ratings and cognitive tests performed via computer interface
Time Frame
Tests taken throughout the protocol, days 1-14
Title
Changes in microbiota, gene expression, epigenetic or proteomic markers
Description
Frequent blood samples and saliva samples
Time Frame
samples taken during forced desychrony (days 7-11) and the constant routine protocols (days 3-4 and 11-13)
Title
Changes in sleep
Description
Polysomnography
Time Frame
sleep periods following day 1, days 6-7 and days 10-11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank A Scheer, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34861073
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.
Results Reference
derived

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Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

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