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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Circadian Based Time Restricted Eating | Experimental | Personalized restricted eating protocol approximately ~4h before DLMO or sleep onset. |
|
| Control | No Intervention | Continue with normal dietary habits and behaviors. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circadian Based Time Restricted Eating | Behavioral | Personalized schedule to restrict eating based on DLMO, approximately ~4h prior to DLMO or sleep onset. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
1. Healthy, overweight or obese individuals.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| 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. | 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. | 46 days |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |