Implications of Circadian Variation of Human Endocannabinoid Levels on Obesity Risk

NCT03000803 | Withdrawn

• 1 other identifier: IRB16-1174
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine how the timing of eating changes 24hr profiles of lipids involved in eating for pleasure and how the body makes and uses energy (metabolism).

Conditions

Obesity

Outcome Measures

Primary Outcomes (4)

• Change in the time of acrophase of the 24hr eCB profile

  A shift in the timing ( time of day, h:mm) of the peak (acrophase) of the eCB rhythm.

  Baseline to Day 38

• Change in appetite/hunger and reward-related eating scores

  The change in the temporal profile of hunger and appetite ratings (measured at 6 time points over a 24hr period) as well as reward-related eating (RRE) from baseline to after the intervention. The ratings of hunger and appetite, and RRE from baseline to intervention will be measured by number rating, on a 10 point scale for hunger and appetite and agree/don't agree or a 5-point scale for the RREs.

  Baseline to Day 38

• Change in glucose tolerance

  The change in glucose tolerance from baseline to after the intervention will be measured. Glucose outcomes from CGM include Mean Absolute Glucose (MAG - mg/dl), Coefficient of Variation (CV - mg/dl), Standard Deviation (SD-mg/dl), Area Under the Curve (AUC - mg/dl), Time Spent in Range (TIR - minutes), Continuous Overall Net Glycemic Action (CONGA - (mg/dl) per minutes ).

  Baseline to Day 38

• Change in insulin sensitivity

  The change in insulin sensitivity from baseline to after the intervention will be measured. Insulin sensitivity measurements from the MMT include area under the curve for insulin (pmol/L) and cpeptide (pmol/L) as well as peak values (pmol/L).

  Baseline to Day 38

Secondary Outcomes (1)

• Change in Weight

  Baseline to Day 38

Study Arms (2)

Early Total Caloric Intake

EXPERIMENTAL

The Early Total Caloric Intake study group will consume the majority of their daily calories during breakfast.

Behavioral: Early Total Caloric Intake

Late Total Caloric Intake

ACTIVE COMPARATOR

The Late Total Caloric Intake study group will consume the majority of their daily calories during dinner.

Behavioral: Late Total Caloric Intake

Interventions

Late Total Caloric Intake BEHAVIORAL

Provide subjects a regimented amount of calories at each meal.

Late Total Caloric Intake

Early Total Caloric Intake BEHAVIORAL

Provide subjects a regimented amount of calories at each meal.

Early Total Caloric Intake

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• self-report sleeping between 7-hrs/night and 9-hrs/night, between 22:00 and 08:00
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin Hanlon, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 22, 2016
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share