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).

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Early Total Caloric Intake; Behavioral: Late Total Caloric Intake

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Hanlon, PhD; Phone Number: 773 834 5849; Email: ehanlon@bsd.uchicago.edu
• Study Contact Backup: Name: Matthew Brady, PhD; Phone Number: (773) 702-2346; Email: mbrady@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Total Caloric Intake; The Early Total Caloric Intake study group will consume the majority of their daily calories during breakfast.	Behavioral: Early Total Caloric Intake; Provide subjects a regimented amount of calories at each meal.
Active Comparator: Late Total Caloric Intake; The Late Total Caloric Intake study group will consume the majority of their daily calories during dinner.	Behavioral: Late Total Caloric Intake; Provide subjects a regimented amount of calories at each meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in timing of peak of endocannabinoid rhythm	The change in the timing (hours) of the peak of the endocannabinoid rhythm from baseline to 37 days after the intervention will be measured.	Day 37

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	The change in weight (kilograms) from baseline to 37 days after intervention will be measured.	Day 37

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Erin Hanlon, PhD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2024
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB16-1174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is currently no plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No