Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05628012 |
| Other study ID # |
STUDY00024761 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2023 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Oregon Health and Science University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
1. 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.
2. 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.
3. 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.
