Shift-work DisorderNCT05153759
EMS Providers' Health Initiative Study
A study testing Meal service in people with Shift-work Disorder, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This study aims to explore dietary factors that influence glycemic control in night shift EMS providers and to test the feasibility of a dietary intervention among these providers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shift-work Disorder
- What is being tested?
- Meal service
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to Dec 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Emergency medical service (EMS) provider
- Works night shift only for at least one year
- Provides patient care as primary duty
Who cannot join
- Diagnosis of a metabolic disease (i.e. diabetes, prediabetes, metabolic syndrome)
- Taking medication to lower blood glucose
- Pregnant or planning to become pregnant
- Diagnosis of kidney disease or impairment
- Allergies or intolerances to study foods
- Digestive disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University at Buffalo
Buffalo, New York, 14214
David Hostler, PhD, 716-829-6795, dhostler@buffalo.edu
Tegan Mansouri, PhD
About this study
This study aims to explore dietary factors that influence glycemic control in night shift EMS providers and to test the feasibility of a dietary intervention among these providers.
Read the detailed description
This study can be broken down into two phases. Both phases will take place over the course of 3 weeks. During the first week, participants will be scheduled for a single 60-90 minute zoom appointment. During this appointment, informed consent will be obtained, participants will provide health and demographic information, complete several questionnaires, and be familiarized with study protocols. The following week, participants will wear a continuous glucose monitor, actigraph activity monitor, document everything they have to eat and drink, and rate their daily stress levels. Participants will continue this during the final week and will be randomized to consume either a 2:1 or 1:1 protein to carbohydrate ratio during the night shift during this week.
- Conditions
- Shift-work Disorder
- Being tested
- Meal service
- Keywords
- EMS, Night shift, Nutrition, Insulin resistance, Circadian rhythm
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal serviceOther
The primary goal is to pilot the feasibility of a meal service intervention in night shift workers
| Study group | Role | What they receive |
|---|---|---|
| High protein | Active comparator | Consuming a meal composed of 2:1 grams of protein to carbohydrate during the night shift between 7pm-7am Receives: Other: Meal service |
| Moderate protein | Placebo comparator | Consuming a meal composed of 1:1 grams of protein to carbohydrate during the night shift between 7pm-7am Receives: Other: Meal service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Daily mean blood glucose
Measured: Two weeks
Compliance
Percent of participants who adhere to the dietary intervention
Measured: Four days
Secondary outcomes (1)
Perceived stress
Daily rating of stress on a scale of one to 10 where 10 is the most stressed the participant has ever been
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start7 Jun 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-work DisorderStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tegan Mansouri, State University of New York at Buffalo
- Investigators
- David Hostler, PhD, Study chair, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153759
- Sponsor's protocol ID
- EMS Health
- Status last verified
- Jan 2026
- First submitted
- 29 Nov 2021
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be de-identified and kept in a password protected database (REDcap.com)
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMS Providers' Health Initiative Study
- ClinicalTrials.gov ID
- NCT05153759
- Acronym / sponsor ID
- EMS Health
- Conditions
- Shift-work Disorder
- Keywords
- EMS, Night shift, Nutrition, Insulin resistance, Circadian rhythm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Dec 2021 (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 aims to explore dietary factors that influence glycemic control in night shift EMS providers and to test the feasibility of a dietary intervention among these providers.
Detailed description
This study can be broken down into two phases. Both phases will take place over the course of 3 weeks. During the first week, participants will be scheduled for a single 60-90 minute zoom appointment. During this appointment, informed consent will be obtained, participants will provide health and demographic information, complete several questionnaires, and be familiarized with study protocols. The following week, participants will wear a continuous glucose monitor, actigraph activity monitor, document everything they have to eat and drink, and rate their daily stress levels. Participants will continue this during the final week and will be randomized to consume either a 2:1 or 1:1 protein to carbohydrate ratio during the night shift during this week.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High protein | Active comparator | Other: Meal serviceConsuming a meal composed of 2:1 grams of protein to carbohydrate during the night shift between 7pm-7am |
| Moderate protein | Placebo comparator | Other: Meal serviceConsuming a meal composed of 1:1 grams of protein to carbohydrate during the night shift between 7pm-7am |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Emergency medical service (EMS) provider
- Works night shift only for at least one year
- Provides patient care as primary duty
Key exclusion criteria (6 listed)
- Diagnosis of a metabolic disease (i.e. diabetes, prediabetes, metabolic syndrome)
- Taking medication to lower blood glucose
- Pregnant or planning to become pregnant
- Diagnosis of kidney disease or impairment
- Allergies or intolerances to study foods
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 |
|---|---|---|
| Meal serviceThe primary goal is to pilot the feasibility of a meal service intervention in night shift workers | Other | High protein, Moderate protein |
Primary outcome
Glycemic control
Time frame: Two weeks
Daily mean blood glucose
Compliance
Time frame: Four days
Percent of participants who adhere to the dietary intervention
1 secondary outcome
Perceived stress
Time frame: Two weeks
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 27 Jan 2026.
- Individual participant dataSharing planned: No. IPD will be de-identified and kept in a password protected database (REDcap.com)
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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.
David Hostler, PhD study chair
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal service in people with Shift-work Disorder, run by State University of New York at Buffalo 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Jan 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. Some participants in this study may receive a placebo. 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?
Contact Tegan H Mansouri, PhD (716-829-5596, teganman@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: Two weeks). The study lists 2 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 27 Jan 2026.