NCT03647306

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Feb 2018Jan 2027

Study Start

First participant enrolled

February 2, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2023

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

5.1 years

First QC Date

August 23, 2018

Last Update Submit

November 13, 2025

Conditions

Type2 Diabetes MellitusCardiovascular Diseases

Keywords

peripheral circadian clockcentral circadian clockschronotypediet

Outcome Measures

Primary Outcomes (1)

  • MI-IS

    The primary outcome measure is the Matsuda Index of Insulin Sensitivity.

    15 days

Study Arms (3)

Extended Overnight Fast

ACTIVE COMPARATOR

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

Early Total Caloric Intake

EXPERIMENTAL

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

Late Total Caloric Intake

EXPERIMENTAL

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

Interventions

Early Total Caloric IntakeBEHAVIORAL

Provide subjects a regimented amount of calories at each meal.

Early Total Caloric Intake
Late Total Caloric IntakeBEHAVIORAL

Provide subjects a regimented amount of calories at each meal.

Late Total Caloric Intake
Extended Overnight FastBEHAVIORAL

Provide subjects a regimented amount of calories at each meal.

Extended Overnight Fast

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (17)

  • Maury E, Hong HK, Bass J. Circadian disruption in the pathogenesis of metabolic syndrome. Diabetes Metab. 2014 Nov;40(5):338-46. doi: 10.1016/j.diabet.2013.12.005. Epub 2014 Jan 14.

    PMID: 24433933RESULT

  • Peek CB, Ramsey KM, Marcheva B, Bass J. Nutrient sensing and the circadian clock. Trends Endocrinol Metab. 2012 Jul;23(7):312-8. doi: 10.1016/j.tem.2012.02.003. Epub 2012 Mar 16.

    PMID: 22424658RESULT

  • Dibner C, Schibler U. Circadian timing of metabolism in animal models and humans. J Intern Med. 2015 May;277(5):513-27. doi: 10.1111/joim.12347. Epub 2015 Feb 6.

    PMID: 25599827RESULT

  • Arble DM, Ramsey KM, Bass J, Turek FW. Circadian disruption and metabolic disease: findings from animal models. Best Pract Res Clin Endocrinol Metab. 2010 Oct;24(5):785-800. doi: 10.1016/j.beem.2010.08.003.

    PMID: 21112026RESULT

  • Gerhart-Hines Z, Lazar MA. Circadian metabolism in the light of evolution. Endocr Rev. 2015 Jun;36(3):289-304. doi: 10.1210/er.2015-1007. Epub 2015 Apr 30.

    PMID: 25927923RESULT

  • Summa KC, Turek FW. Chronobiology and obesity: Interactions between circadian rhythms and energy regulation. Adv Nutr. 2014 May 14;5(3):312S-9S. doi: 10.3945/an.113.005132. Print 2014 May.

    PMID: 24829483RESULT

  • Scheer FA, Hilton MF, Mantzoros CS, Shea SA. Adverse metabolic and cardiovascular consequences of circadian misalignment. Proc Natl Acad Sci U S A. 2009 Mar 17;106(11):4453-8. doi: 10.1073/pnas.0808180106. Epub 2009 Mar 2.

    PMID: 19255424RESULT

  • Morris CJ, Yang JN, Garcia JI, Myers S, Bozzi I, Wang W, Buxton OM, Shea SA, Scheer FA. Endogenous circadian system and circadian misalignment impact glucose tolerance via separate mechanisms in humans. Proc Natl Acad Sci U S A. 2015 Apr 28;112(17):E2225-34. doi: 10.1073/pnas.1418955112. Epub 2015 Apr 13.

    PMID: 25870289RESULT

  • Buxton OM, Cain SW, O'Connor SP, Porter JH, Duffy JF, Wang W, Czeisler CA, Shea SA. Adverse metabolic consequences in humans of prolonged sleep restriction combined with circadian disruption. Sci Transl Med. 2012 Apr 11;4(129):129ra43. doi: 10.1126/scitranslmed.3003200.

    PMID: 22496545RESULT

  • Leproult R, Holmback U, Van Cauter E. Circadian misalignment augments markers of insulin resistance and inflammation, independently of sleep loss. Diabetes. 2014 Jun;63(6):1860-9. doi: 10.2337/db13-1546. Epub 2014 Jan 23.

    PMID: 24458353RESULT

  • McHill AW, Melanson EL, Higgins J, Connick E, Moehlman TM, Stothard ER, Wright KP Jr. Impact of circadian misalignment on energy metabolism during simulated nightshift work. Proc Natl Acad Sci U S A. 2014 Dec 2;111(48):17302-7. doi: 10.1073/pnas.1412021111. Epub 2014 Nov 17.

    PMID: 25404342RESULT

  • Morris CJ, Garcia JI, Myers S, Yang JN, Trienekens N, Scheer FA. The Human Circadian System Has a Dominating Role in Causing the Morning/Evening Difference in Diet-Induced Thermogenesis. Obesity (Silver Spring). 2015 Oct;23(10):2053-8. doi: 10.1002/oby.21189.

    PMID: 26414564RESULT

  • Morris CJ, Purvis TE, Mistretta J, Scheer FA. Effects of the Internal Circadian System and Circadian Misalignment on Glucose Tolerance in Chronic Shift Workers. J Clin Endocrinol Metab. 2016 Mar;101(3):1066-74. doi: 10.1210/jc.2015-3924. Epub 2016 Jan 15.

    PMID: 26771705RESULT

  • Grimaldi D, Carter JR, Van Cauter E, Leproult R. Adverse Impact of Sleep Restriction and Circadian Misalignment on Autonomic Function in Healthy Young Adults. Hypertension. 2016 Jul;68(1):243-50. doi: 10.1161/HYPERTENSIONAHA.115.06847. Epub 2016 Jun 6.

    PMID: 27271308RESULT

  • Gill S, Panda S. A Smartphone App Reveals Erratic Diurnal Eating Patterns in Humans that Can Be Modulated for Health Benefits. Cell Metab. 2015 Nov 3;22(5):789-98. doi: 10.1016/j.cmet.2015.09.005. Epub 2015 Sep 24.

    PMID: 26411343RESULT

  • Zarrinpar A, Chaix A, Panda S. Daily Eating Patterns and Their Impact on Health and Disease. Trends Endocrinol Metab. 2016 Feb;27(2):69-83. doi: 10.1016/j.tem.2015.11.007. Epub 2015 Dec 17.

    PMID: 26706567RESULT

  • Arble DM, Bass J, Behn CD, Butler MP, Challet E, Czeisler C, Depner CM, Elmquist J, Franken P, Grandner MA, Hanlon EC, Keene AC, Joyner MJ, Karatsoreos I, Kern PA, Klein S, Morris CJ, Pack AI, Panda S, Ptacek LJ, Punjabi NM, Sassone-Corsi P, Scheer FA, Saxena R, Seaquest ER, Thimgan MS, Van Cauter E, Wright KP. Impact of Sleep and Circadian Disruption on Energy Balance and Diabetes: A Summary of Workshop Discussions. Sleep. 2015 Dec 1;38(12):1849-60. doi: 10.5665/sleep.5226.

    PMID: 26564131RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Eve Van Cauter, 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

August 23, 2018

First Posted

August 27, 2018

Study Start

February 2, 2018

Primary Completion

March 13, 2023

Study Completion (Estimated)

January 1, 2027

Last Updated

November 14, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)