Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02291952
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 41.4
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Circadian Dysregulation	Behavioral: Meal schedule	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Development of Countermeasures Against Adverse Metabolic Effects of Shift Work
• Actual Study Start Date: Mar 19, 2015
• Actual Primary Completion Date: Aug 29, 2018
• Actual Study Completion Date: Aug 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental During Forced Desynchrony sleep and wake will occur at different circadian phases, while meals are restricted to the biological day.	Behavioral: Meal schedule
Other: Control During Forced Desynchrony sleep and wake, as well as meals, will occur at different circadian phases.	Behavioral: Meal schedule

Outcome Measures

Primary Outcome Measures

1. Change in plasma leptin levels across sleep/wake cycle [During circadian alignment (Day 7) and circadian misalignment (Day 10-11)]

   Frequent blood samples

2. Change in circadian profile of plasma leptin [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 [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 [During circadian alignment (Day 7) and circadian misalignment (Day 10-11)]

   Frequent blood samples

5. Change in plasma insulin levels after standardized test meal [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 [During circadian alignment (Day 7) and circadian misalignment (Day 10-11)]

   Frequent blood samples

Secondary Outcome Measures

1. o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol [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 [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 [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 [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 [sleep periods following day 1, days 6-7 and days 10-11]

   Polysomnography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Frank A Scheer, PhD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frank AJL Scheer, PhD, Frank AJL Scheer, PhD, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02291952
• Other Study ID Numbers: R01HL118601
• First Posted: Nov 17, 2014
• Last Update Posted: Mar 19, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Frank AJL Scheer, PhD, Frank AJL Scheer, PhD, Brigham and Women's Hospital: Circadian Misalignment, Forced Desynchrony, Metabolism, Meal-timing, Circadian
• Additional relevant MeSH terms: Chronobiology Disorders

Study Results

No Results Posted as of Mar 19, 2020