OverweightNCT02298790
Effect of Dietary Habits on Metabolic Health
A study testing Meal schedule in people with Overweight and Obesity, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this application is to understand the connection between people's eating habits and the risk for developing diabetes, obesity, and cardiovascular disease. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Prediabetes
- What is being tested?
- Meal schedule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 21 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 25 and 37.9 kgm-2
- Adults with regular sleep-wake timing
- Non-smokers
- Completion of medical and psychological screening tests
- Able to spend 14 consecutive days in the sleep laboratory
Who cannot join
- BMI < 25 or > 37.9 kgm-2
- History of neurological or psychiatric disorder
- History of sleep disorder or regular use of sleep-promoting medication
- Current prescription, herbal, or over-the-counter medication use
- Traveling across 2 or more time zones within past 3 months
- Donating blood within past 8 weeks
Show all 9Show fewer
- Worked night or rotating shift work within past 3 years
- Hearing impairment
- Drug or alcohol dependency
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The goal of this application is to understand the connection between people's eating habits and the risk for developing diabetes, obesity, and cardiovascular disease.
Read the detailed description
More than a third of U.S. adults are obese (BMI greater than 30), 8-12% of adults suffer from type 2 diabetes, and up to 30% of adults have pre-diabetes. Recent research studies have suggested that it is not just what we eat, but also when we eat that may put us at risk for obesity and type 2 diabetes. Skipping breakfast and eating late at night have been associated with an increased risk for obesity and type 2 diabetes (T2D), substantiated by recent animal and human experimental studies showing that altered meal timing itself, without changes in caloric intake, can influence weight regulation and impaired glucose tolerance. This research will determine in prediabetic and non-diabetic participants whether delaying meal times worsens glucose tolerance, leads to physiological changes favoring a positive energy balance, and increases caloric intake. This research will provide mechanistic insights into the metabolic consequences of changing meal timing and may help in evidence-based approaches to improve dietary interventions in the fight against obesity and T2D.
- Conditions
- Overweight, Obesity, Prediabetes, Meals
- Being tested
- Meal schedule
- Keywords
- Dietary Habits, Circadian, Metabolism, Feeding Behavior
- Medical subject headings
- Overweight, Obesity, Prediabetic State, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal scheduleBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Early Meals | Experimental | Meals are eaten early in the wake episode Receives: Behavioral: Meal schedule |
| Late Meals | Experimental | Meals are eaten late in the wake episode Receives: Behavioral: Meal schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma leptin levels across sleep/wake cycle
Frequent blood samples
Measured: During standardized meals scheduled on Days 3 and 6
Change in circadian profile of plasma leptin
Frequent blood samples
Measured: During constant routine (Days 7-8)
Change in glucose tolerance
Frequent blood samples
Measured: During standardized meals scheduled on Days 3 and 6
Change in circadian profile of plasma glucose levels
Frequent blood samples
Measured: During constant routine (Days 7-8)
Change in plasma insulin levels after standardized test meal
Frequent blood samples
Measured: During standardized meals scheduled on Days 3 and 6
Change in circadian profile of plasma insulin levels
Frequent blood samples
Measured: During constant routine (Days 7-8)
Secondary outcomes (6)
Change in circadian phase markers, such as from core body temperature, melatonin, cortisol
Core temperature and frequent blood samples
Measured: During constant routine (Days 7-8)
Changes circadian rhythm in resting energy expenditure
Indirect calorimetry
Measured: During constant routine (Days 7-8)
Change in hunger and appetite, mood, and cognitive performance
Subjective ratings and cognitive tests performed via computer interface
Measured: Tests taken throughout the protocol, Days 1-9
Changes in microbiota, gene expression, epigenetic or proteomic markers
Frequent blood samples and saliva samples
Measured: Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8)
Changes in sleep
Polysomnography
Measured: Sleep will be measured during the night after Days 2 and 5
Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes
2 fat biopsies, one sample will be taken during each protocol
Measured: On Day 5 of each protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion21 Apr 2019
- Study completion21 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- 18 participants (actual)
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 AJL Scheer, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298790
- Sponsor's protocol ID
- R01DK099512
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2014
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Vujovic N, Koh HE, Heng SW, Panjwani P, Van Zee C, Wang W, Qian J, Garaulet M, Scheer FAJL. Constant-routine protocol reveals an endogenous circadian rhythm in diet-induced thermogenesis with a peak in the biological morning. Metabolism. 2026 Sep;182:156655. doi: 10.1016/j.metabol.2026.156655. Epub 2026 May 25.
PubMed 42190872Vujovic N, Piron MJ, Qian J, Chellappa SL, Nedeltcheva A, Barr D, Heng SW, Kerlin K, Srivastav S, Wang W, Shoji B, Garaulet M, Brady MJ, Scheer FAJL. Late isocaloric eating increases hunger, decreases energy expenditure, and modifies metabolic pathways in adults with overweight and obesity. Cell Metab. 2022 Oct 4;34(10):1486-1498.e7. doi: 10.1016/j.cmet.2022.09.007.
PubMed 36198293
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Habits on Metabolic Health
- ClinicalTrials.gov ID
- NCT02298790
- Acronym / sponsor ID
- R01DK099512
- Conditions
- Overweight, Obesity, Prediabetes, Meals
- Keywords
- Dietary Habits, Circadian, Metabolism, Feeding Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2014
- Primary completion
- 21 Apr 2019 (actual)
- Study completion
- 21 Apr 2019 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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 application is to understand the connection between people's eating habits and the risk for developing diabetes, obesity, and cardiovascular disease.
Detailed description
More than a third of U.S. adults are obese (BMI greater than 30), 8-12% of adults suffer from type 2 diabetes, and up to 30% of adults have pre-diabetes. Recent research studies have suggested that it is not just what we eat, but also when we eat that may put us at risk for obesity and type 2 diabetes. Skipping breakfast and eating late at night have been associated with an increased risk for obesity and type 2 diabetes (T2D), substantiated by recent animal and human experimental studies showing that altered meal timing itself, without changes in caloric intake, can influence weight regulation and impaired glucose tolerance. This research will determine in prediabetic and non-diabetic participants whether delaying meal times worsens glucose tolerance, leads to physiological changes favoring a positive energy balance, and increases caloric intake. This research will provide mechanistic insights into the metabolic consequences of changing meal timing and may help in evidence-based approaches to improve dietary interventions in the fight against obesity and T2D.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Meals | Experimental | Behavioral: Meal scheduleMeals are eaten early in the wake episode |
| Late Meals | Experimental | Behavioral: Meal scheduleMeals are eaten late in the wake episode |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI between 25 and 37.9 kgm-2
- Adults with regular sleep-wake timing
- Non-smokers
- Completion of medical and psychological screening tests
- Able to spend 14 consecutive days in the sleep laboratory
Key exclusion criteria (9 listed)
- BMI < 25 or > 37.9 kgm-2
- History of neurological or psychiatric disorder
- History of sleep disorder or regular use of sleep-promoting medication
- Current prescription, herbal, or over-the-counter medication use
- Traveling across 2 or more time zones within past 3 months
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 schedule | Behavioural | Early Meals, Late Meals |
Primary outcome
Change in plasma leptin levels across sleep/wake cycle
Time frame: During standardized meals scheduled on Days 3 and 6
Frequent blood samples
Change in circadian profile of plasma leptin
Time frame: During constant routine (Days 7-8)
Frequent blood samples
Change in glucose tolerance
Time frame: During standardized meals scheduled on Days 3 and 6
Frequent blood samples
Change in circadian profile of plasma glucose levels
Time frame: During constant routine (Days 7-8)
Frequent blood samples
Change in plasma insulin levels after standardized test meal
Time frame: During standardized meals scheduled on Days 3 and 6
Frequent blood samples
Change in circadian profile of plasma insulin levels
Time frame: During constant routine (Days 7-8)
Frequent blood samples
6 secondary outcomes
Change in circadian phase markers, such as from core body temperature, melatonin, cortisol
Time frame: During constant routine (Days 7-8)
Changes circadian rhythm in resting energy expenditure
Time frame: During constant routine (Days 7-8)
Change in hunger and appetite, mood, and cognitive performance
Time frame: Tests taken throughout the protocol, Days 1-9
Changes in microbiota, gene expression, epigenetic or proteomic markers
Time frame: Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8)
Changes in sleep
Time frame: Sleep will be measured during the night after Days 2 and 5
Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes
Time frame: On Day 5 of each protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 42190872Vujovic N, Koh HE, Heng SW, Panjwani P, Van Zee C, Wang W, Qian J, Garaulet M, Scheer FAJL. Constant-routine protocol reveals an endogenous circadian rhythm in diet-induced thermogenesis with a peak in the biological morning. Metabolism. 2026 Sep;182:156655. doi: 10.1016/j.metabol.2026.156655. Epub 2026 May 25.
- Derived from this study: PubMed 36198293Vujovic N, Piron MJ, Qian J, Chellappa SL, Nedeltcheva A, Barr D, Heng SW, Kerlin K, Srivastav S, Wang W, Shoji B, Garaulet M, Brady MJ, Scheer FAJL. Late isocaloric eating increases hunger, decreases energy expenditure, and modifies metabolic pathways in adults with overweight and obesity. Cell Metab. 2022 Oct 4;34(10):1486-1498.e7. doi: 10.1016/j.cmet.2022.09.007.
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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.
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 Meal schedule in people with Overweight and Obesity, 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 4 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in plasma leptin levels across sleep/wake cycle (time frame: During standardized meals scheduled on Days 3 and 6). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02298790, which also lists 2 linked publications.
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 4 Nov 2020.