Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743271
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2021-01-28
Brief Title:
Food and Circadian Timing
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Uncovering the Impact of Diet on the Human Circadian Timing System
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FACT
Brief Summary:
The goals of this study are to uncover the influence of diet on the human circadian timing system The protocol is a 46-day 28 outpatient days 18 inpatient days over two 9 day visits randomized cross-over study designed to elucidate the speed of entrainment in response to a high-fat diet
Detailed Description:
Synchronization of the timing of biological processes and behaviors with the 24-hour light-dark cycle is fundamental to almost every physiological process cognitive function and overall health As the average circadian period in humans is 9 min longer than the 24-h day and artificial lighting allows a further delay in the clock circadian entrainment must occur every day This makes the process of circadian entrainment of the internal clock with the external environment a commonly overlooked process but one that has serious ramifications if impaired
In rodent models high-fat diets have been shown to disorganize the circadian timing system There has been limited examination however of how composition of diet acts on the circadian timing system in humans The ability to entrain to a new light schedule has been briefly examined after a high-fat diet in rodent modelsWhen mice are exposed to a 6-h shift in the light-dark cycle and fed a diet composed of 50 fat for 3 weeks they experience a 20 slower rate of re-entrainment to the new light cycle as compared to mice fed a low-fat diet Further these mice had an attenuated response to a phase-advancing light pulse Moreover simply providing a high-fat diet to mice results in a lengthened circadian period and a shift in ad libitum eating patterns into the typical rest phase
The goals of this study are to uncover the influence of diet on the human circadian timing system The protocol is a 46-day 28 outpatient days 18 inpatient days over two 9 day visits randomized cross-over study designed to elucidate the speed of entrainment in response to a high-fat diet Participants will be provided 3 weeks of a high-fat diet 2-weeks outpatient 1-week inpatient of 50 calories from fat The protocol includes two types of data collection ambulatory monitoring on strict sleep-wake schedules with either high-fat or low-fat meals provided by the study team and precise in-laboratory measurements of circadian timing entrainment and other physiological markers of sleep and cardiometabolic health
1 Ambulatory Monitoring Participants will maintain a consistent 14-day at home 8h sleep schedule at habitual times before both laboratory visits to ensure 1 subjects are not sleep restricted and 2 that they are obtaining the same light-dark schedule prior to each laboratory visit for stable entrainment verified by actigraphy sleep logs and call-ins to a time stamped recorder Drugs medications caffeine alcohol and nicotine will be proscribed during this time and toxicology analysis will be performed upon in-laboratory admission
2 Outpatient diet For 2-weeks prior to each protocol participants will consume an outpatient isocaloric diet designed to meet individual daily energy requirements diet designed and prepared by investigators Diets will either be designed to be high in calories from fat 50 fat 35 carbohydrate and 15 protein 33 of each mono poly and saturated fat or low-fat 30 fat 55 carbohydrate and 15 protein randomized-crossover design The diet will consist of a breakfast lunch dinner and snack and participants will either come to the laboratory 3 days or staff will deliver meals Participants will be instructed to only consume the food provided during these 14-days Adherence to the diet will be captured via tracking meals using a mobile food tracking application MealLogger AppTM Wellness Foundry New York
3 Inpatient Protocols Participants will be admitted to an individual room free of external time cues eg clocks radios computers visitors and sunlight Room temperature is maintained at 21 - 222 C and light intensity set at 5 lux during scheduled constant posture procedures room light 400 lux during entrainment wakefulness and 0 lux darkness during scheduled sleep opportunities Participants will be instrumented for full polysomnography PSG electrocardiogram and a rectal thermistor for continuous core body temperature measurement An 18-gauge IV catheter will also be inserted into the forearm and connected to a triple-stopcock manifold via an IV loop with a 12- foot small-lumen extension cable through which blood sampling can continue in the next room without disturbing sleep
After instrumentation participants will be given a sleep opportunity and will awakened to dim-lighting and maintaining a constant posture protocol for accurate assessment of circadian phase resting metabolic rate and other physiological outcomes After the constant posture protocol participants light-dark cycle will be changed for 6 identical days followed by a second constant posture protocol for re-assessment of circadian phase This protocol will be repeated while participants are provided the other cross-over meal Investigatorsnurses will be present in the lab or in a central control room 24 h per day to monitor subject health data acquisition provide meals collect biologic specimens perform tests and record sleep A physician is always on call when a participant is in the laboratory An extensive series of protocols and checklists and team practices are used to ensure uniformity in execution of standard procedures
Energy content of diets will be designed to meet individual daily energy requirements Dietitians will prepare isocaloric meals containing macronutrient contents of high or low-fat diet and no caffeine Caloric intake will be the same caloric and macronutrient composition for each day of laboratory study and will be provided as miniature snacks frequently during each constant posture protocol eg ΒΌ turkey cheese sandwich juice and water
In rodent models high-fat diets have been shown to disorganize the circadian timing system There has been limited examination however of how composition of diet acts on the circadian timing system in humans The ability to entrain to a new light schedule has been briefly examined after a high-fat diet in rodent modelsWhen mice are exposed to a 6-h shift in the light-dark cycle and fed a diet composed of 50 fat for 3 weeks they experience a 20 slower rate of re-entrainment to the new light cycle as compared to mice fed a low-fat diet Further these mice had an attenuated response to a phase-advancing light pulse Moreover simply providing a high-fat diet to mice results in a lengthened circadian period and a shift in ad libitum eating patterns into the typical rest phase
The goals of this study are to uncover the influence of diet on the human circadian timing system The protocol is a 46-day 28 outpatient days 18 inpatient days over two 9 day visits randomized cross-over study designed to elucidate the speed of entrainment in response to a high-fat diet Participants will be provided 3 weeks of a high-fat diet 2-weeks outpatient 1-week inpatient of 50 calories from fat The protocol includes two types of data collection ambulatory monitoring on strict sleep-wake schedules with either high-fat or low-fat meals provided by the study team and precise in-laboratory measurements of circadian timing entrainment and other physiological markers of sleep and cardiometabolic health
1 Ambulatory Monitoring Participants will maintain a consistent 14-day at home 8h sleep schedule at habitual times before both laboratory visits to ensure 1 subjects are not sleep restricted and 2 that they are obtaining the same light-dark schedule prior to each laboratory visit for stable entrainment verified by actigraphy sleep logs and call-ins to a time stamped recorder Drugs medications caffeine alcohol and nicotine will be proscribed during this time and toxicology analysis will be performed upon in-laboratory admission
2 Outpatient diet For 2-weeks prior to each protocol participants will consume an outpatient isocaloric diet designed to meet individual daily energy requirements diet designed and prepared by investigators Diets will either be designed to be high in calories from fat 50 fat 35 carbohydrate and 15 protein 33 of each mono poly and saturated fat or low-fat 30 fat 55 carbohydrate and 15 protein randomized-crossover design The diet will consist of a breakfast lunch dinner and snack and participants will either come to the laboratory 3 days or staff will deliver meals Participants will be instructed to only consume the food provided during these 14-days Adherence to the diet will be captured via tracking meals using a mobile food tracking application MealLogger AppTM Wellness Foundry New York
3 Inpatient Protocols Participants will be admitted to an individual room free of external time cues eg clocks radios computers visitors and sunlight Room temperature is maintained at 21 - 222 C and light intensity set at 5 lux during scheduled constant posture procedures room light 400 lux during entrainment wakefulness and 0 lux darkness during scheduled sleep opportunities Participants will be instrumented for full polysomnography PSG electrocardiogram and a rectal thermistor for continuous core body temperature measurement An 18-gauge IV catheter will also be inserted into the forearm and connected to a triple-stopcock manifold via an IV loop with a 12- foot small-lumen extension cable through which blood sampling can continue in the next room without disturbing sleep
After instrumentation participants will be given a sleep opportunity and will awakened to dim-lighting and maintaining a constant posture protocol for accurate assessment of circadian phase resting metabolic rate and other physiological outcomes After the constant posture protocol participants light-dark cycle will be changed for 6 identical days followed by a second constant posture protocol for re-assessment of circadian phase This protocol will be repeated while participants are provided the other cross-over meal Investigatorsnurses will be present in the lab or in a central control room 24 h per day to monitor subject health data acquisition provide meals collect biologic specimens perform tests and record sleep A physician is always on call when a participant is in the laboratory An extensive series of protocols and checklists and team practices are used to ensure uniformity in execution of standard procedures
Energy content of diets will be designed to meet individual daily energy requirements Dietitians will prepare isocaloric meals containing macronutrient contents of high or low-fat diet and no caffeine Caloric intake will be the same caloric and macronutrient composition for each day of laboratory study and will be provided as miniature snacks frequently during each constant posture protocol eg ΒΌ turkey cheese sandwich juice and water
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None