CompletedNot Applicable

Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

United States20 participantsStarted 2015-03-19

Plain-language summary

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

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in plasma leptin levels across sleep/wake cycle

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

Change in circadian profile of plasma leptin

Timeframe: During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)

Change in glucose tolerance

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

Change in circadian profile of plasma glucose levels

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

Change in plasma insulin levels after standardized test meal

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

Change in circadian profile of plasma insulin levels

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

Trial details

NCT IDNCT02291952

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-08-29

View on ClinicalTrials.gov More Circadian Dysregulation trials

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in plasma leptin levels across sleep/wake cycle

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

Change in circadian profile of plasma leptin

Timeframe: During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)

Change in glucose tolerance

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

Change in circadian profile of plasma glucose levels

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

Change in plasma insulin levels after standardized test meal

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

Change in circadian profile of plasma insulin levels

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