Circadian Time Restricted Eating
CTRE
Circadian Based Time-Restricted Eating Paradigm to Improve Cardiometabolic Health and Prevent Disease
1 other identifier
interventional
10
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2022
CompletedFirst Posted
Study publicly available on registry
November 28, 2022
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 3, 2024
April 1, 2024
1.7 years
November 16, 2022
April 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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.
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.
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.
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.
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.
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.
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.
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.
46 days
Secondary Outcomes (3)
Changes in Body Fat Percentage
46 days
Changes in Weight
46 days
Changes in Body Mass Index
46 days
Study Arms (2)
Circadian Based Time Restricted Eating
EXPERIMENTALPersonalized restricted eating protocol approximately \~4h before DLMO or sleep onset.
Control
NO INTERVENTIONContinue with normal dietary habits and behaviors.
Interventions
Personalized schedule to restrict eating based on DLMO, approximately \~4h prior to DLMO or sleep onset.
Eligibility Criteria
You may qualify if:
- \. Healthy, overweight or obese individuals.
You may not qualify if:
- 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).
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health and Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2022
First Posted
November 28, 2022
Study Start
April 1, 2023
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
April 3, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share