Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

Mass General Brigham

Status: Completed

Conditions: Circadian Dysregulation

Treatments: Behavioral: Meal schedule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02291952

R01HL118601

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Experimental

Experimental group

Description:

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

Treatment:

Behavioral: Meal schedule

Control

Other group

Description:

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

Treatment:

Behavioral: Meal schedule