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Behavioral Chronotype: Impact on Sleep and Metabolism

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ClinicalTrials.gov Identifier: NCT03647306
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Northwestern University
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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 if metabolism changes with age.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Mellitus Cardiovascular Diseases Behavioral: Early Total Caloric Intake Behavioral: Late Total Caloric Intake Behavioral: Extended Overnight Fast Not Applicable

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, insulin sensitivity, and cardiovascular disease risk. This study will provide proof-of-concept evidence on the impact of misalignment on glucose metabolism and blood pressure regulation. 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 24hr profiles of hormones involved in circadian timing, food intake and cardiovascular risk in a session that will mimic habitual sleep/wake and caloric distribution. Participants will then be randomized to one of three groups in which caloric distribution across the day will either be equally distributed between 3 meals, or heavily weighted to the morning or heavily weighted to the evening. During a 6-day semi-ambulatory 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. After 7 days of this caloric distribution intervention, we will then repeat the short laboratory session to assess whether the intervention of caloric distribution altered any of the measured profiles. The outcome measures will be the timing of the dim light melatonin onset (DLMO), blood pressure dipping, and insulin sensitivity. The proposed work will provide unambiguous evidence related to the efficacy of a novel lifestyle intervention - that could be more acceptable than dietary restriction or exercise - to reduce the risk of T2DM and CVD in adults at risk due to age and degree of adiposity. Moreover, our project will examine both middle-aged adults and older adults. The younger age group is of interest because of a lesser burden of illness and of an opportunity to alter the trajectory of aging at an earlier stage. The older age group is expected to have more severe circadian disturbances at baseline, with the potential of a larger effect on CM risk. The combined examination of metabolic risk and CVD risk in the context of circadian function is also novel.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Behavioral Chronotype: Impact on Sleep and Metabolism
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Extended Overnight Fast
The extended overnight fast group will have scheduled meal times for the entire 6 day semi ambulatory and in lab session. Subjects will consume approximately 33% of their daily calories at breakfast, lunch and dinner, respectively. This is a model for fasting dietary chronotype.
Behavioral: Extended Overnight Fast
Provide subjects a regimented amount of calories at each meal.

Experimental: Early Total Caloric Intake
The Early Total Caloric Intake study group will have scheduled meal times for the entire 6 day semi ambulatory and in lab session and will consume 60% of their daily calories during breakfast. The remaining 40% of daily calories will be consumed during lunch and dinner. This is a model for early dietary chronotype.
Behavioral: Early Total Caloric Intake
Provide subjects a regimented amount of calories at each meal.

Experimental: Late Total Caloric Intake
The Late Total Caloric Intake study group will have scheduled meal times for the entire 6 day semi ambulatory and in lab session and will consume 40% of daily calories during breakfast and lunch. The remaining 60% of daily calories will be consumed during dinner. This is a model for late dietary chronotype.
Behavioral: Late Total Caloric Intake
Provide subjects a regimented amount of calories at each meal.




Primary Outcome Measures :
  1. MI-IS [ Time Frame: 15 days ]
    The primary outcome measure is the Matsuda Index of Insulin Sensitivity.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy overweight and obese (25 kg/m2 ≤BMI< 40 kg/m2) men and women
  • aged 30-75 years
  • self-report sleeping at least 6.5-hrs/night but no more than 9-hrs/night, between 21:00 and 09:00
  • signed informed consent

Exclusion Criteria:

  • participation in a medically managed weight loss program within the past year
  • undergone bariatric surgery
  • dietary restrictions
  • Subjects will not have undergone surgery, donated a unit of blood, worked night shifts or crossed any time zones, or participated in another clinical study within a month prior to the study.
  • pregnancy in women
  • lactating women
  • Female subjects must not be actively going through menopause.
  • prisoners
  • inability to consent
  • members of the study team
  • Females with a hemoglobin < 11.5g/dL, and males with a hemoglobin < 13.5 g/dl will be excluded from the study.
  • presence of a sleep disorder such as moderate or severe sleep apnea (AHI≥15), a Circadian Rhythm Sleep Disorder (DSM-V criteria for advance sleep phase syndrome, delayed sleep phase syndrome, non 24-h sleep disorder, irregular sleep disorder and shift-work related sleep disorder),
  • a diagnosis of diabetes based on history or screening tests
  • other forms of endocrine dysfunction including PCOS;
  • a history of cognitive or other neurological disorders;
  • a history of major psychiatric disorder based on DSM-V criteria,
  • the presence of unstable or serious medical conditions,
  • any GI disease that requires dietary adjustment;
  • current, or use within the past month of melatonin, psychoactive, hypnotic, stimulant or pain medications (except occasionally); beta blockers; habitual smoking (6 or more cigarettes per week); caffeine consumption of greater than 500 mg per day

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): NCT03647306


Contacts
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Contact: Melanie Norstrom, PhD 773 702 1991 mnorstrom@medicine.bsd.uchicago.edu
Contact: Erin Hanlon, PhD 773 834 5849 ehanlon@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Eve Van Cauter, PhD    773-702-0169    evcauter@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
National Institute on Aging (NIA)
Northwestern University
Investigators
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Principal Investigator: Eve Van Cauter, PhD University of Chicago

Publications of Results:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03647306     History of Changes
Other Study ID Numbers: IRB17-1768
P01AG011412 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 University of Chicago:
peripheral circadian clock
central circadian clocks
chronotype
diet

Additional relevant MeSH terms:
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Diabetes Mellitus
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases