CM: Circadian Misalignment and Energy Balance

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03663530
Collaborator
NYU Langone Health (Other)
42
1
2
53.9
0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Meal times
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This is a 2-period crossover study in which sleep is identical in duration and timing but meals/food intake is varied relative to the sleep episode.This is a 2-period crossover study in which sleep is identical in duration and timing but meals/food intake is varied relative to the sleep episode.
Masking:
None (Open Label)
Masking Description:
Participants will be masked to the true outcomes of the study.
Primary Purpose:
Prevention
Official Title:
Impact of Circadian Misalignment on Energy Balance Regulation
Actual Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Energy expenditure [Change over 2-week period]

    Metabolic chamber

  2. Body composition [Change over 4-week period]

    Quantitative magnetic resonance

  3. Nutritional intakes [4 weeks]

    3-day food records

Secondary Outcome Measures

  1. Task-based functional neuroimaging [Change over 2-week period]

    Brain responses to food stimuli

  2. Resting state functional neuroimaging [Change over 2-week period]

    Functional neuroimaging

  3. Appetite [4 weeks]

    Visual analog scales

  4. Hormones [Change over 2-week period]

    Leptin, ghrelin, peptide tyrosine tyrosine, glucagon-like peptide 1

Other Outcome Measures

  1. Circadian rhythms [Change over 2-week period]

    Melatonin and cortisol

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 49 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All racial and ethnic groups

  • Body mass index 25-34.9 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York Obesity Nutrition Research Center New York New York United States 10032

Sponsors and Collaborators

  • Columbia University
  • NYU Langone Health

Investigators

  • Principal Investigator: Marie-Pierre St-Onge, PhD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marie-Pierre St-Onge, Associate Professor, Columbia University
ClinicalTrials.gov Identifier:
NCT03663530
Other Study ID Numbers:
  • AAAR9547
First Posted:
Sep 10, 2018
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marie-Pierre St-Onge, Associate Professor, Columbia University

Study Results

No Results Posted as of Feb 11, 2022