Shift Work Type Circadian Rhythm Sleep DisorderNCT04468672
Eating Behaviors in Shift Workers
A study testing Portion size in people with Shift Work Type Circadian Rhythm Sleep Disorder and Eating Behavior, run by Columbia University at 1 site in United States.
Trial summary
This study will compare eating behaviors and measures of hunger and fullness between day and night workers in order to better understand why night workers are at increased risk for obesity and related diseases. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift Work Type Circadian Rhythm Sleep Disorder, Eating Behavior
- What is being tested?
- Portion size
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2020to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Work ~ 8-hour shifts during day or night on 3 or more consecutive days of the week
- BMI 19-35 kg/m^2
- Age 20-55 years of age
- Metabolically healthy
- Weight stable over previous 3 months
- Lives in New York City area
Who cannot join
- Pregnant or less than 1 year postpartum at time of study
- Smoking
- History of drug or alcohol abuse
- Rotating shift work
- Habitual sleep duration of more than 6 hour per night
- Obstructive sleep apnea
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- Transmeridian travel
- Type 2 diabetes
- Cardiovascular disease
- Hypertension
- Participation in diet or weight loss program in the 3 months prior to enrollment
- Psychiatric or sleep disorder
- Food allergies or intolerances
- Dislike of or unwillingness to eat test foods
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: The Interaction of Shift Work and Food Environment on Eating Behaviors and Appetite
This study will compare eating behaviors and measures of hunger and fullness between day and night workers in order to better understand why night workers are at increased risk for obesity and related diseases.
- Being tested
- Portion size
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portion sizeBehavioural
The amount of food served (g) at the first two meals of each day. These amounts will vary across 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Day worker | Active comparator | Men and women who work only day shift for at least 3 consecutive days of the week Receives: Behavioral: Portion size |
| Night worker | Active comparator | Men and women who work only night shift for at least 3 consecutive days of the week Receives: Behavioral: Portion size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Food by weight (g) in response to variations in portion served
Measured: 24-hours intake period
Energy intake
Food by energy (kcal) in response to variations in portion served
Measured: 24-hours intake period
Energy density consumed
Energy density consumed (kcal/g) in response to variations in portion served
Measured: 24-hours intake period
Secondary outcomes (2)
Appetite-regulating hormones
Appetite-regulating hormones, including Glucagon-like-peptide 1 (GLP-1) and ghrelin will be analyzed from plasma from whole blood samples collected while fasted and at 30, 60, 90, and 120 min postprandial. Area under the curve of plasma concentrations will be calculated for each individual appetite-regulating hormone
Measured: 2-hours measurement period
Hunger and fullness
Subjective measures related to hunger, fullness, and prospective consumption will be measured before and after meals via visual analog scales. The range of scores are 0 mm to 100 mm, with higher scores indicating greater feelings of the corresponding measure (e.g. greater hunger). Post-meal measures, adjusted for the corresponding pre-meal measure, will be analyzed as individual outcomes. Area under the curve will also be calculated for each measure.
Measured: 24-hours measurement period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start14 Dec 2020
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift Work Type Circadian Rhythm Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a mixed design with two participant groups (between-subject), day and night workers, each being exposed to 4 levels of food portion size (within-subjects factor)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Faris M Zuraikat, PhD, Principal investigator, Columbia UniversityMarie-Pierre St-Onge, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468672
- Sponsor's protocol ID
- AAAS8559
- Status last verified
- Feb 2026
- First submitted
- 30 Jun 2020
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared with other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction of Shift Work and Food Environment on Eating Behaviors and Appetite
- ClinicalTrials.gov ID
- NCT04468672
- Acronym / sponsor ID
- AAAS8559
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare eating behaviors and measures of hunger and fullness between day and night workers in order to better understand why night workers are at increased risk for obesity and related diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a mixed design with two participant groups (between-subject), day and night workers, each being exposed to 4 levels of food portion size (within-subjects factor)
| Arm | Type | Receives |
|---|---|---|
| Day worker | Active comparator | Behavioral: Portion sizeMen and women who work only day shift for at least 3 consecutive days of the week |
| Night worker | Active comparator | Behavioral: Portion sizeMen and women who work only night shift for at least 3 consecutive days of the week |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Work ~ 8-hour shifts during day or night on 3 or more consecutive days of the week
- BMI 19-35 kg/m^2
- Age 20-55 years of age
- Metabolically healthy
- Weight stable over previous 3 months
Key exclusion criteria (14 listed)
- Pregnant or less than 1 year postpartum at time of study
- Smoking
- History of drug or alcohol abuse
- Rotating shift work
- Habitual sleep duration of more than 6 hour per night
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portion sizeThe amount of food served (g) at the first two meals of each day. These amounts will vary across 4 weeks. | Behavioural | Day worker, Night worker |
Primary outcome
Food intake
Time frame: 24-hours intake period
Food by weight (g) in response to variations in portion served
Energy intake
Time frame: 24-hours intake period
Food by energy (kcal) in response to variations in portion served
Energy density consumed
Time frame: 24-hours intake period
Energy density consumed (kcal/g) in response to variations in portion served
2 secondary outcomes
Appetite-regulating hormones
Time frame: 2-hours measurement period
Hunger and fullness
Time frame: 24-hours measurement period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared with other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faris M Zuraikat, PhD principal investigator
Columbia University
Marie-Pierre St-Onge, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portion size in people with Shift Work Type Circadian Rhythm Sleep Disorder and Eating Behavior, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake (time frame: 24-hours intake period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.