Recruiting

Circadian Eating

Sponsor:

Oregon Health and Science University

Code:

NCT05628012

Conditions

Circadian Rhythm

Cardiometabolic Health

Weight Loss

Cardiovascular Health

Time Restricted Feeding

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Circadian Based Time Restricted Eating

Study Details

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.

Conditions

Circadian Rhythm

Cardiometabolic Health

Weight Loss

Cardiovascular Health

Time Restricted Feeding

Study ID

NCT05628012

Start date

Apr 1, 2023

Status verified date

Apr, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Healthy, overweight or obese individuals.

Exclusion Criteria:

1. Participants must have a body mass index (BMI) greater than or equal to 27 kilograms per meter squared.
2. 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.
3. 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.
4. Chronobiologic and sleep disorders.
5. Diseases of the cardiovascular system.
6. 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).
7. Disorders of the respiratory system.
8. 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%).
9. Disorders of the kidney and urinary tract.
10. Infectious diseases.
11. Disorders of the gastrointestinal system.
12. Disorders of the immune system.
13. Disorders of the hematopoietic system.
14. Neoplastic diseases.
15. Endocrine and metabolic diseases.
16. Neurologic disorders.
17. Must not be participating in another research study that would influence their safe participation in the study.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Circadian Based Time Restricted Eating

Personalized restricted eating protocol approximately \~4h before DLMO or sleep onset.

no intervention: Control

Continue with normal dietary habits and behaviors.

Interventions

Circadian Based Time Restricted Eating

Personalized schedule to restrict eating based on DLMO, approximately \~4h prior to DLMO or sleep onset.

Primary outcome measure

  • Dim-Light Melatonin Onset [ Time Frame: 7.5 hours ]
  • Changes in Blood Pressure [ Time Frame: 46 days ]
  • Changes in Heart Rate [ Time Frame: 46 days ]
  • Changes in Hemoglobin A1c [ Time Frame: 46 days ]
  • Changes in Total Cholesterol [ Time Frame: 46 days ]
  • Changes in LDL and HDL cholesterol [ Time Frame: 46 days ]
  • Changes in Triglycerides [ Time Frame: 46 days ]
  • Changes in Glucose [ Time Frame: 46 days ]

Central Contacts and Locations

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 3, 2024

Last verified

Apr, 2024

Keywords

  • Circadian Rhythm
  • Weight Loss
  • Cardiovascular Health
  • Cardiometabolic Health
  • Time Restricted Feeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-04-03.