Dietary HabitsNCT04868526
Dietary Intervention to Mitigate Adverse Consequences of Night Work
A study testing dietary intervention in people with Dietary Habits, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to test whether our dietary intervention can prevent or lessen the negative health effects of night shift work in healthy participants. Participants will: complete 2 inpatient stays be provided with identical meals have frequent blood draws provide urine, saliva, stool and rectal… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 1 Sep 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 yr old
- BMI 20.0-29.9
- European/Hispanic/African-American ancestry
- No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)
Who cannot join
- Currently smoking/vaping or 5 or more years of smoking/vaping
- History of drug or alcohol dependency
- History of psychiatric illness or 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
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Han-Chow Koh, PhD, 6172780924
Frank Scheer, PhD
About this study
The goal of this clinical trial is to test whether our dietary intervention can prevent or lessen the negative health effects of night shift work in healthy participants.
Participants will:
- complete 2 inpatient stays
- be provided with identical meals
- have frequent blood draws
- provide urine, saliva, stool and rectal swab samples
Read the detailed description
Shift work increases the risk for diabetes possibly due to the adverse metabolic effects of circadian misalignment. As shift work is not foreseen to disappear, the development of individually-targeted therapies for metabolic health in these vulnerable shift workers is urgently needed. This research will determine whether our dietary intervention can mitigate the adverse metabolic effects of circadian misalignment, which may help in the design of evidence-based dietary interventions to improve the metabolic health in shift workers.
- Conditions
- Dietary Habits
- Being tested
- dietary intervention
- Keywords
- Night shift work, Glucose tolerance
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary interventionBehavioural
Research participants will be assigned to two dietary conditions.
| Study group | Role | What they receive |
|---|---|---|
| Control-Dietary Intervention | Experimental | Control condition first, then the Dietary intervention. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes. Receives: Behavioral: dietary intervention |
| Dietary intervention-Control | Experimental | Dietary intervention first, then the Control condition. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes. Receives: Behavioral: dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose tolerance from Baseline to Test Day
Change in incremental glucose area under the curve (AUC) from a mixed meal test.
Measured: Baseline (Day 2) and Test Day (Day 4)
Changes in microbial community structure/composition/function of oral and gut microbiome from Baseline to Test Day
Shotgun metagenomics sequencing or 16S rRNA sequencing of saliva, stool, and rectal swab samples will provide in-depth interrogation of the microbial community structure, composition, and function.
Measured: Baseline (Day 2) and Test Day (Day 4)
Secondary outcomes (4)
Change in insulin sensitivity (Oral Minimal Model method) from Baseline to Test Day
Oral Minimal Model method estimates insulin sensitivity based on blood glucose and insulin levels from a mixed meal test.
Measured: Baseline (Day 2) and Test Day (Day 4)
Change in levels of serum markers of gut microbiota from Baseline to Test Day
Levels of markers of gut microbiota (e.g. short chain fatty acids) will be measured in serum samples taken 3-hourly over 24 hr.
Measured: Baseline (Day 2) and Test Day (Day 4)
Change in levels of serum markers of intestinal barrier integrity from Baseline to Test Day
Levels of markers of intestinal barrier integrity (e.g. zonulin, LPS, LBP) will be measured in serum samples taken 3-hourly over 24 hr.
Measured: Baseline (Day 2) and Test Day (Day 4)
Change in level of serum markers of inflammatory state from Baseline to Test Day
Levels of markers of inflammatory state (e.g., cytokines) will be measured in serum samples taken 3-hourly over 24 hr.
Measured: Baseline (Day 2) and Test Day (Day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start29 Mar 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Frank AJL Scheer, PhD, Brigham and Women's Hospital
- Investigators
- Frank Scheer, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868526
- Sponsor's protocol ID
- 2021P000683
- Other IDs
- R01HL153969
- Status last verified
- Nov 2025
- First submitted
- 23 Apr 2021
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention to Mitigate Adverse Consequences of Night Work
- ClinicalTrials.gov ID
- NCT04868526
- Acronym / sponsor ID
- 2021P000683
- Conditions
- Dietary Habits
- Keywords
- Night shift work, Glucose tolerance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 May 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.
The goal of this clinical trial is to test whether our dietary intervention can prevent or lessen the negative health effects of night shift work in healthy participants.
Participants will:
- complete 2 inpatient stays
- be provided with identical meals
- have frequent blood draws
- provide urine, saliva, stool and rectal swab samples
Detailed description
Shift work increases the risk for diabetes possibly due to the adverse metabolic effects of circadian misalignment. As shift work is not foreseen to disappear, the development of individually-targeted therapies for metabolic health in these vulnerable shift workers is urgently needed. This research will determine whether our dietary intervention can mitigate the adverse metabolic effects of circadian misalignment, which may help in the design of evidence-based dietary interventions to improve the metabolic health in shift workers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-Dietary Intervention | Experimental | Behavioral: dietary interventionControl condition first, then the Dietary intervention. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes. |
| Dietary intervention-Control | Experimental | Behavioral: dietary interventionDietary intervention first, then the Control condition. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-45 yr old
- BMI 20.0-29.9
- European/Hispanic/African-American ancestry
- No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)
Key exclusion criteria (3 listed)
- Currently smoking/vaping or 5 or more years of smoking/vaping
- History of drug or alcohol dependency
- History of psychiatric illness or disorder
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 |
|---|---|---|
| dietary interventionResearch participants will be assigned to two dietary conditions. | Behavioural | Control-Dietary Intervention, Dietary intervention-Control |
Primary outcome
Change in glucose tolerance from Baseline to Test Day
Time frame: Baseline (Day 2) and Test Day (Day 4)
Change in incremental glucose area under the curve (AUC) from a mixed meal test.
Changes in microbial community structure/composition/function of oral and gut microbiome from Baseline to Test Day
Time frame: Baseline (Day 2) and Test Day (Day 4)
Shotgun metagenomics sequencing or 16S rRNA sequencing of saliva, stool, and rectal swab samples will provide in-depth interrogation of the microbial community structure, composition, and function.
4 secondary outcomes
Change in insulin sensitivity (Oral Minimal Model method) from Baseline to Test Day
Time frame: Baseline (Day 2) and Test Day (Day 4)
Change in levels of serum markers of gut microbiota from Baseline to Test Day
Time frame: Baseline (Day 2) and Test Day (Day 4)
Change in levels of serum markers of intestinal barrier integrity from Baseline to Test Day
Time frame: Baseline (Day 2) and Test Day (Day 4)
Change in level of serum markers of inflammatory state from Baseline to Test Day
Time frame: Baseline (Day 2) and Test Day (Day 4)
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 5 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Frank Scheer, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention in people with Dietary Habits, run by Brigham and Women's Hospital 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 4 inclusion and 3 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 5 Dec 2025. 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?
Contact Megan Munn (6175258259, mmunn@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose tolerance from Baseline to Test Day (time frame: Baseline (Day 2) and Test Day (Day 4)). 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 5 Dec 2025.