Dietary HabitsNCT05862818
Can Food Timing Reduce Your Diabetes Risk?
A study testing Day shift protocol - Diet order A-B, Day shift protocol - Diet order B-A and Night shift protocol - Diet order A-B 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 food timing impacts metabolic health in healthy participants. Participants will: complete 2 inpatient stays be provided with test meals have frequent blood draws 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?
- Day shift protocol - Diet order A-B, Day shift protocol - Diet order B-A and Night shift protocol - Diet order A-B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2024to 30 Jun 2028
- Phase
- Interventional
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
- Healthy with no acute or chronic medical and psychiatric disorders
- BMI: 18.5-29.9 kg/m2
Who cannot join
- Smokers, current tobacco or e-cigarette use
- Drug or alcohol dependency
- Pregnant
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
Frank Scheer, PhD, 617-732-14, fscheer@bwh.harvard.edu
Frank Scheer, PhD
About this study
The goal of this clinical trial is to test whether food timing impacts metabolic health in healthy participants.
Participants will:
- complete 2 inpatient stays
- be provided with test meals
- have frequent blood draws
Read the detailed description
The investigators aim to investigate the influence of different food timing, without changing 24-h caloric and nutrient intake, on glucose and fat tolerance and energy expenditure in healthy people on a simulated day or night shift.
- Conditions
- Dietary Habits
- Being tested
- Day shift protocol - Diet order A-B, Day shift protocol - Diet order B-A, Night shift protocol - Diet order A-B, Night shift protocol - Diet order B-A
- Keywords
- Glucose tolerance, Diet-induced thermogenesis, Fat 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.
Day shift protocol - Diet order A-BBehavioural
Research participants will be assigned to day shift condition and Diet A-B order condition.
Day shift protocol - Diet order B-ABehavioural
Research participants will be assigned to day shift condition and Diet B-A order condition.
Night shift protocol - Diet order A-BBehavioural
Research participants will be assigned to simulated night shift condition and Diet A-B order condition.
Night shift protocol - Diet order B-ABehavioural
Research participants will be assigned to simulated night shift condition and Diet B-A order condition.
| Study group | Role | What they receive |
|---|---|---|
| Day shift protocol with diet A | Experimental | Day shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. Receives: Behavioral: Day shift protocol - Diet order A-B; Behavioral: Day shift protocol - Diet order B-A |
| Day shift protocol with diet B | Experimental | Day shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. Receives: Behavioral: Day shift protocol - Diet order A-B; Behavioral: Day shift protocol - Diet order B-A |
| Night shift protocol with diet A | Experimental | Night shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. Receives: Behavioral: Night shift protocol - Diet order A-B; Behavioral: Night shift protocol - Diet order B-A |
| Night shift protocol with diet B | Experimental | Night shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. Receives: Behavioral: Night shift protocol - Diet order A-B; Behavioral: Night shift protocol - Diet order B-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in glucose tolerance between Meal Conditions and Shift Work
Glucose incremental area under the curve (AUC) from mixed meal tests
Measured: 24 hours
Difference in diet-induced thermogenesis between Meal Conditions and Shift Work
Postprandial energy expenditure incremental area under the curve (AUC) from mixed meal tests
Measured: 24 hours
Difference in plasma triglyceride level between Meal Conditions and Shift Work
Triglyceride area under the curve (AUC) over 24 hours
Measured: 24 hours
Secondary outcomes (6)
Difference in insulin sensitivity between Meal Conditions and Shift Work
Insulin sensitivity index derived from Oral Minimal Model
Measured: 24 hours
Difference in beta-cell function between Meal Conditions and Shift Work
Beta-cell function index derived from Oral Minimal Model
Measured: 24 hours
Difference in 24-h glycemia between Meal Conditions and Shift Work
Glucose area under the curve (AUC) based on CGM over 24 hours
Measured: 24 hours
Difference in postprandial incretin level between Meal Conditions and Shift Work
Incretin incremental area under the curve (AUC) from mixed meal tests
Measured: 24 hours
Difference in substrate oxidation between Meal Conditions and Shift Work
Postprandial substrate oxidation incremental area under the curve (AUC) from mixed meal tests
Measured: 24 hours
Difference in plasma free fatty acids level between Meal Conditions and Shift Work
Free fatty acids area under the curve (AUC) over 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start10 Dec 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT05862818
- Sponsor's protocol ID
- 2023P001063
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No