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Circadian Misalignment and Energy Balance (CM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663530
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
NYU Langone Health
Information provided by (Responsible Party):
Marie-Pierre St-Onge, Columbia University

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
Obesity Behavioral: Meal times Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : January 1, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

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




Primary Outcome Measures :
  1. Energy expenditure [ Time Frame: Change over 2-week period ]
    Metabolic chamber

  2. Body composition [ Time Frame: Change over 4-week period ]
    Quantitative magnetic resonance

  3. Nutritional intakes [ Time Frame: 4 weeks ]
    3-day food records


Secondary Outcome Measures :
  1. Task-based functional neuroimaging [ Time Frame: Change over 2-week period ]
    Brain responses to food stimuli

  2. Resting state functional neuroimaging [ Time Frame: Change over 2-week period ]
    Functional neuroimaging

  3. Appetite [ Time Frame: 4 weeks ]
    Visual analog scales

  4. Hormones [ Time Frame: Change over 2-week period ]
    Leptin, ghrelin, peptide tyrosine tyrosine, glucagon-like peptide 1


Other Outcome Measures:
  1. Circadian rhythms [ Time Frame: Change over 2-week period ]
    Melatonin and cortisol



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663530


Contacts
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Contact: Theresa Pizinger, MS 212-851-5583 tmp2125@cumc.columbia.edu
Contact: Ismel Salazar, MS is2527@cumc.columbia.edu

Locations
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United States, New York
New York Obesity Nutrition Research Center Recruiting
New York, New York, United States, 10032
Contact: Theresa Pizinger, MS    212-851-5583    tmp2125@cumc.columbia.edu   
Contact: Ismel Salazar, MS    212-851-5578    is2527@cumc.columbia.edu   
Principal Investigator: Marie-Pierre St-Onge, PhD         
Sponsors and Collaborators
Columbia University
NYU Langone Health
Investigators
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Principal Investigator: Marie-Pierre St-Onge, PhD Columbia University Irving Medical Center
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Responsible Party: Marie-Pierre St-Onge, Associate Professor, Columbia University
ClinicalTrials.gov Identifier: NCT03663530    
Other Study ID Numbers: AAAR9547
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will become available after results of the main aims from the final dataset have been accepted for publication.
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.

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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, Columbia University:
Food intake
Energy expenditure
Body composition
Meal timing