Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

NCT ID: NCT02291952

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-19

Study Completion Date

2018-08-29

Brief Summary

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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

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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.

Conditions

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Circadian Dysregulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Meal schedule

Intervention Type BEHAVIORAL

Control

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

Group Type OTHER

Meal schedule

Intervention Type BEHAVIORAL

Interventions

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Meal schedule

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frank AJL Scheer, PhD

Frank AJL Scheer, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank A Scheer, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34861073 (View on PubMed)

Other Identifiers

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R01HL118601

Identifier Type: NIH

Identifier Source: org_study_id

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