Circadian Misalignment and Energy Balance (CM)

Impact of Circadian Misalignment on Energy Balance Regulation

Preliminary findings from the investigators' lab suggest that circadian misalignment, occurring when meals and sleep are mistimed from one another, alters resting state neuronal processing in areas relevant to food reward and interoception; supporting a role of sleep and meal misalignment, on energy balance regulation. No study has been done to disentangle the effects of sleep and meal timing on body weight regulation, independent of sleep duration. This study will provide information to guide messaging related to timing of meals and sleep that can be translated to individuals whose sleep follows unconventional times, such as shift workers and those with jetlag and social jetlag.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Meal times

Detailed Description

The proposed study will test whether the misalignment of eating occasions to the sleep period influences health markers. The goal of the proposed study is to determine whether eating out of synchrony with sleep influences risk of chronic diseases. The proposed study has both mechanistic and translational objectives. First, the investigators will test whether eating late in the day will influence energy balance (hormones, energy expenditure, nutritional intakes). Next, they will observe how misaligned meals, relative to aligned meals, influence behavior. Overweight men and women will be recruited to participate in a 2-phase, crossover study, with constant sleep periods. Phases will only differ in the alignment of meals to the sleep period: aligned = meals starting 1 h after awakening; misaligned = meals starting 5 h after awakening. Mechanistic aims will be addressed from measurements taken after 3 and 14 d of the intervention. The translational aim will be addressed after a 4 wk free-living period following the prescribed meal times for each phase. This proposed study, which will manipulate meal timing, without affecting total sleep time, is important because it will provide information on the mechanism by which circadian misalignment influences health. As such, the proposed study will be a stepping-stone in the establishment of lifestyle recommendations or therapies to personalize chronotype to reduce the risk of chronic diseases.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lena Navarro; Phone Number: 347-963-8845; Email: lrn2116@cumc.columbia.edu
• Study Contact Backup: Name: Claudia Dreyer; Phone Number: 347-881-6008; Email: cd3003@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Principal Investigator: Marie-Pierre St-Onge, PhD
      • Contact: Claudia Dreyer, MS; Email: cd3003@cumc.columbia.edu
      • Contact: Lena Navarro; Email: lrn2116@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All racial and ethnic groups
• Body mass index 20-34.9 kg/m2
• Average sleep duration ≥7 hour/night, assessed during 2-week screening period
• Eat within 1 hour of awakening at least 5 days/week
• Midpoint of sleep at 4 AM or earlier

Exclusion Criteria:

• <10 nights of sleep <7 hour during the 2-week screening period
• Daytime napping
• Current or past sleep disorder (Sleep Disorders Inventory); Insomnia Severity Index Score >10
• Current or past psychiatric disorder, including eating disorders and seasonal affective disorder
• Any psychological or psychiatric disorder deemed to interfere with study outcomes
• Smoking (currently smoking any cigarettes or using tobacco products, e-cigarettes and vapes, or ex-smokers <3 years)
• Night and rotating shift work
• Travel across time zones within 4 wk of the study
• History of drug or alcohol abuse or excessive alcohol consumption (>3 drinks/day for men or 2 for women)
• Recent weight change (>5% gain or loss of body weight over past 3 months) or active participation in diet or weight loss program in previous 3 months; any weight loss procedure
• Pregnancy or <1 year post-partum
• Diagnosed sleep apnea or high-risk score on Berlin questionnaire (2 or more categories with positive score)
• Depression (score >13 on Beck Depression Inventory II) or taking anti-depressive medications
• Restless leg syndrome and circadian rhythm disorders
• Dementia or cognitive impairments
• Taking psychoactive or hypnotic medications
• Taking chronic analgesic or anti-inflammatory medications
• Having had gastrointestinal surgery, including gastric bypass surgery
• Restrained eating or abnormal scores on the Three Factor Eating Questionnaire
• Contraindications for magnetic resonance imaging scanning
• Hematocrit <30%
• Taking beta blockers, as this can interfere with melatonin secretion

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Circadian misalignment; Meals in this condition will be delayed by 4 hours relative to the circadian alignment condition. Food intake during this period will be from 1 PM to 11 PM.	Behavioral: Meal times; Meal times vary based on the arm: aligned or misaligned
Active Comparator: Circadian alignment; Meals in this condition will be aligned to the sleep episode. Food intake during this period will be from 9 AM to 7 PM.	Behavioral: Meal times; Meal times vary based on the arm: aligned or misaligned

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy expenditure	Metabolic chamber	Change over 2-week period
Body composition	Quantitative magnetic resonance	Change over 4-week period
Nutritional intakes	3-day food records	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Task-based functional neuroimaging	Brain responses to food stimuli	Change over 2-week period
Resting state functional neuroimaging	Functional neuroimaging	Change over 2-week period
Appetite	Visual analog scales	4 weeks
Hormones	Leptin, ghrelin, peptide tyrosine tyrosine, glucagon-like peptide 1	Change over 2-week period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circadian rhythms	Melatonin and cortisol	Change over 2-week period

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: NYU Langone Health
• Investigators: Principal Investigator: Marie-Pierre St-Onge, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Energy expenditure; Body composition; Food intake; Meal timing
• Other Study ID Numbers: AAAR9547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this study will be available for sharing with other investigators. Data sharing requests should be made in writing and sent directly to the investigator(s) who generated the data. The purposes for using shared data should be stated in the request, and the data can only be used for research purposes. Data sharing agreements should be developed and accepted by both parties before data sharing takes place. Protecting the rights and privacy of human subjects and maintaining the study participants' confidentiality will be the first priority of our data sharing plan. We plan to follow the HIPAA privacy rule for de-identification of a dataset before transferring data.
• IPD Sharing Time Frame: Data will become available after results of the main aims from the final dataset have been accepted for publication.
• IPD Sharing Access Criteria: Our methods of data sharing include: mailing CD-ROM containing data or e-mailing data files directly to the requestors. Normally, our data files are available in Excel or SAS format. Other data file formats can also be requested. The study's Statisticians will assist in preparing the required data files for data sharing. fMRI data will be uploaded to a data file sharing repository for anyone to use. These data will be de-identified prior to release.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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