Dietary InterventionEATSNCT05800990
Eating to Adjust the Timing System
A study testing dietary intervention in people with Dietary Intervention, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the effects of dietary composition on the rhythms of food intake, appetite regulation, and rhythms of energy expenditure. Participants will: complete 2 field-based dietary interventions be provided with standard meals record daily food intake in a real-time manner complete 2… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Intervention
- 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
- 8 Nov 2024to 31 Aug 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 yr old
- BMI 18.5-29.9
- No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)
- Without medication use (except oral contraceptives)
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
- People with food allergies/intolerances or following specific diets
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
Arman Arab, PhD, 617-278-0703, aarab1@mgb.org
Rahul Reddy, Bsc, 617-525-8259, rmreddy@bwh.harvard.edu
About this study
Official title: Do Dietary Patterns Influence Your Weight Management and Circadian Rhythms?
The goal of this clinical trial is to test the effects of dietary composition on the rhythms of food intake, appetite regulation, and rhythms of energy expenditure.
Participants will:
complete 2 field-based dietary interventions be provided with standard meals record daily food intake in a real-time manner complete 2 inpatient stays be provided with standard meals have frequent blood draws provide urine, saliva, and stool samples
Read the detailed description
Obesity is an ongoing epidemic and a serious public health problem. Recent insights into the involvement of the circadian system (i.e., an internal biological rhythm) in energy expenditure and appetite control offer a new perspective to understand the relationship between dietary composition and weight management. Particularly, dietary composition may impact whole-body physiology in part through changes in the circadian system. The study protocol is designed to test the effects of dietary composition, on the rhythms of food intake and appetite regulation, and rhythms of energy expenditure. This study seeks to understand the relationship between dietary composition and weight control in order to lay the groundwork for evidence-based dietary intervention to combat obesity.
- Conditions
- Dietary Intervention
- Being tested
- dietary intervention
- Keywords
- circadian rhythm, energy expenditure, appetite regulation
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 |
|---|---|---|
| Dietary A-B Intervention | Experimental | The Dietary A first, then the Dietary B 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 B-A Intervention | Experimental | The Dietary B first, then the Dietary A 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian phase of melatonin rhythm
Hourly plasma melatonin will be measured under the Constant Routine condition
Measured: Days 18-19
Percentage of daily caloric intake in the biological evening
Percentage of caloric intake within the 4 hours before bedtime will be derived from real-time record of food and beverage intake during the intervention period
Measured: Days 8-14
Secondary outcomes (3)
Circadian amplitude of melatonin rhythm
Hourly circulating melatonin will be measured under the Constant Routine condition
Measured: Days 18-19
Circadian amplitude of subjective hunger rhythms
Hourly subjective hunger will be measured by Visual Analog Scale under the Constant Routine condition
Measured: Days 18-19
Circadian phase of resting energy expenditure
Every other hour energy expenditure will be measured by indirect calorimetry under the Constant Routine condition
Measured: Days 18-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start8 Nov 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary InterventionStudies 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 Institutes of Health (NIH)
- Responsible party
- Principal investigator, Frank AJL Scheer, PhD, Brigham and Women's Hospital
- Investigators
- Frank AJL Scheer, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800990
- Sponsor's protocol ID
- 2023P000622
- Acronym
- EATS
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2023
- Last updated
- 20 Oct 2026
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Dietary Patterns Influence Your Weight Management and Circadian Rhythms?
- ClinicalTrials.gov ID
- NCT05800990
- Acronym / sponsor ID
- EATS / 2023P000622
- Conditions
- Dietary Intervention
- Keywords
- circadian rhythm, energy expenditure, appetite regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Apr 2023 (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 the effects of dietary composition on the rhythms of food intake, appetite regulation, and rhythms of energy expenditure.
Participants will:
complete 2 field-based dietary interventions be provided with standard meals record daily food intake in a real-time manner complete 2 inpatient stays be provided with standard meals have frequent blood draws provide urine, saliva, and stool samples
Detailed description
Obesity is an ongoing epidemic and a serious public health problem. Recent insights into the involvement of the circadian system (i.e., an internal biological rhythm) in energy expenditure and appetite control offer a new perspective to understand the relationship between dietary composition and weight management. Particularly, dietary composition may impact whole-body physiology in part through changes in the circadian system. The study protocol is designed to test the effects of dietary composition, on the rhythms of food intake and appetite regulation, and rhythms of energy expenditure. This study seeks to understand the relationship between dietary composition and weight control in order to lay the groundwork for evidence-based dietary intervention to combat obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary A-B Intervention | Experimental | Behavioral: dietary interventionThe Dietary A first, then the Dietary B 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 B-A Intervention | Experimental | Behavioral: dietary interventionThe Dietary B first, then the Dietary A 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. |
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 18.5-29.9
- No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)
- Without medication use (except oral contraceptives)
Key exclusion criteria (4 listed)
- Currently smoking/vaping or 5 or more years of smoking/vaping
- History of drug or alcohol dependency
- History of psychiatric illness or disorder
- People with food allergies/intolerances or following specific diets
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 | Dietary A-B Intervention, Dietary B-A Intervention |
Primary outcome
Circadian phase of melatonin rhythm
Time frame: Days 18-19
Hourly plasma melatonin will be measured under the Constant Routine condition
Percentage of daily caloric intake in the biological evening
Time frame: Days 8-14
Percentage of caloric intake within the 4 hours before bedtime will be derived from real-time record of food and beverage intake during the intervention period
3 secondary outcomes
Circadian amplitude of melatonin rhythm
Time frame: Days 18-19
Circadian amplitude of subjective hunger rhythms
Time frame: Days 18-19
Circadian phase of resting energy expenditure
Time frame: Days 18-19
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 20 Oct 2026.
- 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 AJL 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 Intervention, 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 4 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 20 Oct 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?
Contact Frank A.J.L. Scheer, PhD (617-732-7014, FSCHEER@BWH.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian phase of melatonin rhythm (time frame: Days 18-19). 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 20 Oct 2026.