CLINICAL TRIAL / NCT03000803
Circadian Control of Human Circulating Endocannabinoid Levels
- Interventional
- Active
- NCT03000803
Contact Information
Circadian Control of Human Circulating Endocannabinoid Levels
The purpose of this study is to examine how the timing of eating changes how the body makes and uses energy (metabolism). This study will also examine how fat cells respond to insulin (a hormone that controls blood sugar levels).
The timing of food intake and caloric distribution across the 24hr day are emerging as
contributing factors to weight gain. The idea that not only what you eat, but when you eat
can contribute to weight gain has garnered interest from both the scientific community and
the public. In fact, the distribution of caloric intake over the 24hr day has been recently
recognized as a potential source of "circadian misalignment" which can result in adverse
health outcomes, including overeating, impaired glucose tolerance and insulin sensitivity.
Moreover, reward driven eating (eating for the pleasurable aspect instead of energy need)
generally results in caloric intake well in excess of energy requirements and is recognized
as a major culprit in the epidemic of obesity. The endocannabinoid (eCB) system is involved
in both homeostatic processes (energy need only) that govern food intake, and has been shown
to play a key role in reward eating. Thus, the role of circadian organization of the eCB
system and how misalignment may contribute to overeating, overweight, obesity, and diabetes
is the main focus of this study. The overall goal is to determine whether the timing of food
intake is a major determinant of the 24 hour variation in eCB activity that in turn affects
hunger and appetite, glucose metabolism, and insulin sensitivity. This study will focus on
overweight individuals who are at high risk of obesity but are still on a trajectory that can
potentially be reversed by lifestyle changes. Following a careful assessment of the subject's
habitual sleep and meal timing and caloric distribution under real life conditions, a short
laboratory study will determine whether participants who consume more of their daily calories
later in the day (later dietary chronotype) display delays in the eCB rhythm and lower
insulin sensitivity. During a 6-day in patient intervention, combining laboratory and
ambulatory procedures, study procedures will assess the effect of experimentally changing
caloric distribution across the day, advancing versus delaying the dietary chronotype. The
outcome measures will be the timing of the daily peak of the eCB rhythm and insulin
sensitivity. This study will also measure the potential durability of the intervention on
subsequent habitual behavior under real life conditions, in that how long does one maintain
the feeding in lab imposed feeding schedule and does that schedule effect subsequent behavior
and/or weight. Identification of circadian misalignment of the eCB system as a mediator of
increased food intake and reduced insulin sensitivity may help develop novel preventive
strategies.
Gender
All
Age Group
19 Years to 40 Years
Accepting Healthy Volunteers
Accepts Healthy Volunteers
Inclusion Criteria:
- self-report sleeping between 7-hrs/night and 9-hrs/night, between 22:00 and 08:00
- self-report having gained at least 3lbs in the last year
Exclusion Criteria:
- no previously diagnosed sleep disorders (including obstructive sleep apnea (OSA))
- no existing diagnosis of prediabetes or diabetes
- no history of endocrine dysfunction
- no history of psychiatric, cardiovascular, or eating disorders
- must not have a gastro-intestinal disease that requires dietary adjustment
- currently taking no medications (including birth control)
- drug and nicotine use, habitual alcohol use of more than 2 drinks per day, and
caffeine intake of more than 300 mg per day
- anyone who has participated in medically managed weight loss program within the past
year,
- anyone who has undergone bariatric surgery,
- must not have dietary restrictions
- must not work night shifts or crossed any time zones in the month prior to the study.
- Obesity