Circadian RhythmCTRENCT05628012
Circadian Time Restricted Eating
A study testing Circadian Based Time Restricted Eating in people with Circadian Rhythm and Cardiometabolic Health, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goal of this study is to learn more about how the time in which participants consume their meals relative to their personalized circadian rhythm influences their overall cardiometabolic health and weight. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm, Cardiometabolic Health, Weight Loss
- What is being tested?
- Circadian Based Time Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 1 Dec 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy, overweight or obese individuals.
Who cannot join
- Participants must have a body mass index (BMI) greater than or equal to 27 kilograms per meter squared.
- No history of drug or alcohol dependency. Must be current non-smokers, and are required to have a history of less than 5 pack years of smoking.
- No history of working irregular day and night hours, regular night work, or rotating shift work for the 1 year prior to the study. In addition to this, individuals must not have traveled across more than 1 time zone during the 3 months prior to the study.
- Chronobiologic and sleep disorders.
- Diseases of the cardiovascular system.
- Hypertension. Individuals will be allowed to be normotensive (resting systolic blood pressure of <140/90 mmHg, measured on more than one occasion) or uncomplicated stage 1 hypertension (systolic BP between 140 and 159 mmHg or a diastolic BP between 90 and 99 mmHg).
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- Disorders of the respiratory system.
- Pre-diabetes/Diabetes. For participants who have a fasting blood glucose level that is greater than or equal to 100 mg/dL, the investigators will measure hemoglobin A1c to exclude for diabetes (HbA1c>5.7%).
- Disorders of the kidney and urinary tract.
- Infectious diseases.
- Disorders of the gastrointestinal system.
- Disorders of the immune system.
- Disorders of the hematopoietic system.
- Neoplastic diseases.
- Endocrine and metabolic diseases.
- Neurologic disorders.
- Must not be participating in another research study that would influence their safe participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Andrew McHill, PhD, 503-494-2594, mchill@ohsu.edu
About this study
Official title: Circadian Based Time-Restricted Eating Paradigm to Improve Cardiometabolic Health and Prevent Disease
The goal of this study is to learn more about how the time in which participants consume their meals relative to their personalized circadian rhythm influences their overall cardiometabolic health and weight. The investigators are hoping to discover if a circadian-based time restricted eating intervention will improve cardiometabolic health and decrease weight. The protocol is a 46 day prospective cohort study that includes both field and in-laboratory data collection in overweight and obese individuals.
Read the detailed description
A vast majority of research has focused on the over consumption of foods, dietary patterns, and inactivity as causes of weight gain. There is growing evidence which suggests that calories consumed during the night might be responsible for weight gain than calories consumed during the day. Although, intermittent fasting interventions have become popular, there are currently no interventions that take the circadian timing of eating into account. In this pilot cohort, the investigators will determine the impact of a personalized circadian-timed intervention on cardiometabolic health and weight management in overweight adults.
There is data that demonstrates that the time in which an individual eats relative to their circadian night is associated with a higher body fat composition, regardless of the amount or content of their meals, and lower energy expenditure. Furthermore, it has also been shown that circadian phase (e.g., time of meal during day or night) has an independent adverse effect on glucose metabolism, and late meal timing may impair glucose tolerance. Although "time-restricted feeding" interventions have focused on drastic reductions in the time interval between first and last daily meal consumption, independent of circadian phase, and have observed improved cardiometabolic health and weight loss, they may not be as beneficial for health or practical for all individuals as clock hour may not accurately reflect internal circadian time. Our preliminary data shows that similarly-aged individuals living in the same city exhibit a range of >11h difference in the timing of DLMO. Thus, a strict time cut-off to stop consuming calories may work for some individuals, but not for others.
The goals of this study are to create a personalized, circadian-based time restricted feeding intervention for each participant, that will acutely (5 weeks) improve cardiometabolic health independent of weight loss in overweight adults, as well as chronically (16 weeks) decrease weight and improve cardiometabolic health in overweight adults. The protocol is a 46 day prospective cohort study that includes both field and in-laboratory data collection in overweight and obese individuals. Participants will adhere to a restricted-eating schedule for approximately 46 days or 16 weeks and will be asked to otherwise maintain their regular eating habits. Based on preliminary data, the outcomes that the investigators will focus on will be indices of hemodynamics (blood pressure, heart rate), cholesterol (total, low-density and high-density lipoproteins), hemoglobin A1c, weight, and percent body fat.
- Biobehavioral Laboratory Visit: Participants will be asked to visit the OHSU SON Biobehavioral Laboratory space in dim-light settings, which will involve an evening stay (~7.5h) to measure circadian markers, body composition, blood pressure, and questionnaire data. Saliva samples will also be collected via salivettes in order to measure the hormone melatonin and determine each participants' dim-light melatonin onset (DLMO). Participants will then be randomized into either continuing their regular behaviors or be assigned a personalized eating schedule that they will maintain for up to 16 weeks.
- Ambulatory Monitoring: Participants who were assigned a personalized eating schedule will adhere to their schedule for the duration of the study (46 days or 16 weeks) and will intermittently keep track of their eating schedule and sleep to ensure the protocol is being followed. This includes not eating within a 4-hour window of DLMO and sleep onset. Participants who were not assigned a restricted eating schedule will continue with their normal dietary habits. During weeks 0 (baseline), 1, 5, 10 and 16, participants will be asked to wear an actigraphy device, keep sleep logs, and track all meals using a mobile food track application. Drugs, medications, caffeine, alcohol, and nicotine are prohibited for the duration of the study and a toxicology analysis will be performed during the initial biobehavioral laboratory visit.
- Blood Biomarkers: At baseline, week 5, and week 16, participants will visit the OCTRI outpatient clinic for a blood draw to obtain blood lipids, glucose, and hemoglobin A1c, as well as other blood variables that will be measured with an ~10mL blood draw.
- Conditions
- Circadian Rhythm, Cardiometabolic Health, Weight Loss, Cardiovascular Health, Time Restricted Feeding
- Being tested
- Circadian Based Time Restricted Eating
- Keywords
- Circadian Rhythm, Weight Loss, Cardiovascular Health, Cardiometabolic Health, Time Restricted Feeding
- Medical subject headings
- Weight Loss, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian Based Time Restricted EatingBehavioural
Personalized schedule to restrict eating based on DLMO, approximately ~4h prior to DLMO or sleep onset.
| Study group | Role | What they receive |
|---|---|---|
| Circadian Based Time Restricted Eating | Experimental | Personalized restricted eating protocol approximately ~4h before DLMO or sleep onset. Receives: Behavioral: Circadian Based Time Restricted Eating |
| Control | No intervention | Continue with normal dietary habits and behaviors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dim-Light Melatonin Onset
Saliva samples will be collected during baseline week and will be assayed for melatonin using standardized assays. Dim-light melatonin onset will be calculated using the linear interpolated point in time in which each participant's melatonin crosses and remains elevated above a 4pg/mL threshold.
Measured: 7.5 hours
Changes in Blood Pressure
Changes in resting blood pressure will be measured every ~30 minutes via ambulatory blood pressure machines for up to 48-hours during weeks 0, 1, 5, 10, and 16. Blood pressure patterns during the day and night will be assessed, as well as a contrast of day and night time blood pressure levels. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Measured: 46 days
Changes in Heart Rate
Heart rate will be measured every ~30 minutes via a blood pressure cuff. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Measured: 46 days
Changes in Hemoglobin A1c
Changes in Hemoglobin A1c (HbA1c) will be measured during weeks 1, 5, and 16. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Measured: 46 days
Changes in Total Cholesterol
Changes in total cholesterol will be measured during weeks 1, 5, and 16. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Measured: 46 days
Changes in LDL and HDL cholesterol
Changes in HDL and LDL cholesterol will be measured during weeks 1, 5, and 16. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Measured: 46 days
Changes in Triglycerides
Changes in triglycerides will be measured during weeks 1, 5, and 16. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Measured: 46 days
Changes in Glucose
Changes in glucose will be measured during weeks 1, 5, and 16. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Measured: 46 days
Secondary outcomes (3)
Changes in Body Fat Percentage
Percent body fat will be measured via a Tanita body composition scale. Hip, waist, and neck measurements will also be taken. Measurements for body fat percentage will occur during baseline, week 1, week 5, week 10, and week 16. Examined using planned comparison dependent t-tests between the baseline and the sixteen-week visit. These data will be used to calculate mean difference and standard deviations between the control and experimental group for future experiments.
Measured: 46 days
Changes in Weight
Weight will be measured using a Tanita body composition scale during weeks 0, 1, 5, 10, and week 16. Examined using planned comparison dependent t-tests between the baseline and the sixteen-week visit. These data will be used to calculate mean difference and standard deviations between the control and experimental group for future experiments.
Measured: 46 days
Changes in Body Mass Index
Changes in BMI will be measured using a Tanita body composition scale during weeks 0, 1, 5, 10, and week 16. It will be calculated using standard equations with height and weight. Examined using planned comparison dependent t-tests between the baseline and the sixteen-week visit. These data will be used to calculate mean difference and standard deviations between the control and experimental group for future experiments.
Measured: 46 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Apr 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628012
- Sponsor's protocol ID
- STUDY00024761
- Acronym
- CTRE
- Status last verified
- Apr 2024
- First submitted
- 16 Nov 2022
- Last updated
- 3 Apr 2024
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Based Time-Restricted Eating Paradigm to Improve Cardiometabolic Health and Prevent Disease
- ClinicalTrials.gov ID
- NCT05628012
- Acronym / sponsor ID
- CTRE / STUDY00024761
- Conditions
- Circadian Rhythm, Cardiometabolic Health, Weight Loss, Cardiovascular Health, Time Restricted Feeding
- Keywords
- Circadian Rhythm, Weight Loss, Cardiovascular Health, Cardiometabolic Health, Time Restricted Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 28 Nov 2022 (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 study is to learn more about how the time in which participants consume their meals relative to their personalized circadian rhythm influences their overall cardiometabolic health and weight. The investigators are hoping to discover if a circadian-based time restricted eating intervention will improve cardiometabolic health and decrease weight. The protocol is a 46 day prospective cohort study that includes both field and in-laboratory data collection in overweight and obese individuals.
Detailed description
A vast majority of research has focused on the over consumption of foods, dietary patterns, and inactivity as causes of weight gain. There is growing evidence which suggests that calories consumed during the night might be responsible for weight gain than calories consumed during the day. Although, intermittent fasting interventions have become popular, there are currently no interventions that take the circadian timing of eating into account. In this pilot cohort, the investigators will determine the impact of a personalized circadian-timed intervention on cardiometabolic health and weight management in overweight adults.
There is data that demonstrates that the time in which an individual eats relative to their circadian night is associated with a higher body fat composition, regardless of the amount or content of their meals, and lower energy expenditure. Furthermore, it has also been shown that circadian phase (e.g., time of meal during day or night) has an independent adverse effect on glucose metabolism, and late meal timing may impair glucose tolerance. Although "time-restricted feeding" interventions have focused on drastic reductions in the time interval between first and last daily meal consumption, independent of circadian phase, and have observed improved cardiometabolic health and weight loss, they may not be as beneficial for health or practical for all individuals as clock hour may not accurately reflect internal circadian time. Our preliminary data shows that similarly-aged individuals living in the same city exhibit a range of >11h difference in the timing of DLMO. Thus, a strict time cut-off to stop consuming calories may work for some individuals, but not for others.
The goals of this study are to create a personalized, circadian-based time restricted feeding intervention for each participant, that will acutely (5 weeks) improve cardiometabolic health independent of weight loss in overweight adults, as well as chronically (16 weeks) decrease weight and improve cardiometabolic health in overweight adults. The protocol is a 46 day prospective cohort study that includes both field and in-laboratory data collection in overweight and obese individuals. Participants will adhere to a restricted-eating schedule for approximately 46 days or 16 weeks and will be asked to otherwise maintain their regular eating habits. Based on preliminary data, the outcomes that the investigators will focus on will be indices of hemodynamics (blood pressure, heart rate), cholesterol (total, low-density and high-density lipoproteins), hemoglobin A1c, weight, and percent body fat.
- Biobehavioral Laboratory Visit: Participants will be asked to visit the OHSU SON Biobehavioral Laboratory space in dim-light settings, which will involve an evening stay (~7.5h) to measure circadian markers, body composition, blood pressure, and questionnaire data. Saliva samples will also be collected via salivettes in order to measure the hormone melatonin and determine each participants' dim-light melatonin onset (DLMO). Participants will then be randomized into either continuing their regular behaviors or be assigned a personalized eating schedule that they will maintain for up to 16 weeks.
- Ambulatory Monitoring: Participants who were assigned a personalized eating schedule will adhere to their schedule for the duration of the study (46 days or 16 weeks) and will intermittently keep track of their eating schedule and sleep to ensure the protocol is being followed. This includes not eating within a 4-hour window of DLMO and sleep onset. Participants who were not assigned a restricted eating schedule will continue with their normal dietary habits. During weeks 0 (baseline), 1, 5, 10 and 16, participants will be asked to wear an actigraphy device, keep sleep logs, and track all meals using a mobile food track application. Drugs, medications, caffeine, alcohol, and nicotine are prohibited for the duration of the study and a toxicology analysis will be performed during the initial biobehavioral laboratory visit.
- Blood Biomarkers: At baseline, week 5, and week 16, participants will visit the OCTRI outpatient clinic for a blood draw to obtain blood lipids, glucose, and hemoglobin A1c, as well as other blood variables that will be measured with an ~10mL blood draw.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circadian Based Time Restricted Eating | Experimental | Behavioral: Circadian Based Time Restricted EatingPersonalized restricted eating protocol approximately ~4h before DLMO or sleep onset. |
| Control | No intervention | –Continue with normal dietary habits and behaviors. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Healthy, overweight or obese individuals.
Key exclusion criteria (17 listed)
- Participants must have a body mass index (BMI) greater than or equal to 27 kilograms per meter squared.
- No history of drug or alcohol dependency. Must be current non-smokers, and are required to have a history of less than 5 pack years of smoking.
- No history of working irregular day and night hours, regular night work, or rotating shift work for the 1 year prior to the study. In addition to this, individuals must not have traveled across more than 1 time zone during the 3 months prior to the study.
- Chronobiologic and sleep disorders.
- Diseases of the cardiovascular system.
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 |
|---|---|---|
| Circadian Based Time Restricted EatingPersonalized schedule to restrict eating based on DLMO, approximately ~4h prior to DLMO or sleep onset. | Behavioural | Circadian Based Time Restricted Eating |
Primary outcome
Dim-Light Melatonin Onset
Time frame: 7.5 hours
Saliva samples will be collected during baseline week and will be assayed for melatonin using standardized assays. Dim-light melatonin onset will be calculated using the linear interpolated point in time in which each participant's melatonin crosses and remains elevated above a 4pg/mL threshold.
Changes in Blood Pressure
Time frame: 46 days
Changes in resting blood pressure will be measured every ~30 minutes via ambulatory blood pressure machines for up to 48-hours during weeks 0, 1, 5, 10, and 16. Blood pressure patterns during the day and night will be assessed, as well as a contrast of day and night time blood pressure levels. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Changes in Heart Rate
Time frame: 46 days
Heart rate will be measured every ~30 minutes via a blood pressure cuff. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Changes in Hemoglobin A1c
Time frame: 46 days
Changes in Hemoglobin A1c (HbA1c) will be measured during weeks 1, 5, and 16. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Changes in Total Cholesterol
Time frame: 46 days
Changes in total cholesterol will be measured during weeks 1, 5, and 16. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Changes in LDL and HDL cholesterol
Time frame: 46 days
Changes in HDL and LDL cholesterol will be measured during weeks 1, 5, and 16. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Changes in Triglycerides
Time frame: 46 days
Changes in triglycerides will be measured during weeks 1, 5, and 16. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
Changes in Glucose
Time frame: 46 days
Changes in glucose will be measured during weeks 1, 5, and 16. Examined using planned comparison dependent t-tests between the baseline and the five-week visit. These data will be used to calculate mean differences and standard deviations between the control and experimental group for future experiments.
3 secondary outcomes
Changes in Body Fat Percentage
Time frame: 46 days
Changes in Weight
Time frame: 46 days
Changes in Body Mass Index
Time frame: 46 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian Based Time Restricted Eating in people with Circadian Rhythm and Cardiometabolic Health, run by Oregon Health and Science University 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 1 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dim-Light Melatonin Onset (time frame: 7.5 hours). The study lists 8 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 3 Apr 2024.