Study Summary
This trial will study how the timing of meals affects metabolism and if metabolism changes with age.
Eligible Conditions
- Cardiovascular Disease
- Type 2 Diabetes
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 15 days
15 days
MI-IS
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Extended Overnight Fast
1 of 3
Early Total Caloric Intake
1 of 3
Late Total Caloric Intake
1 of 3
Active Control
Experimental Treatment
200 Total Participants · 3 Treatment Groups
Primary Treatment: Early Total Caloric Intake · No Placebo Group · N/A
Early Total Caloric Intake
Behavioral
Experimental Group · 1 Intervention: Early Total Caloric Intake · Intervention Types: BehavioralLate Total Caloric Intake
Behavioral
Experimental Group · 1 Intervention: Late Total Caloric Intake · Intervention Types: BehavioralExtended Overnight Fast
Behavioral
ActiveComparator Group · 1 Intervention: Extended Overnight Fast · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 days
Who is running the clinical trial?
Northwestern UniversityOTHER
1,450 Previous Clinical Trials
785,729 Total Patients Enrolled
University of ChicagoLead Sponsor
924 Previous Clinical Trials
753,128 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,413 Previous Clinical Trials
3,484,016 Total Patients Enrolled
Eve Van Cauter, PhDPrincipal InvestigatorUniversity of Chicago
9 Previous Clinical Trials
743 Total Patients Enrolled
Eligibility Criteria
Age 30 - 75 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Pennsylvania | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Chicago | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Scheer, Frank A. J. L., Michael F. Hilton, Christos S. Mantzoros, and Steven A. Shea. 2009. “Adverse Metabolic and Cardiovascular Consequences of Circadian Misalignment”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.0808180106.
- Gill, Shubhroz, and Satchidananda Panda. 2015. “A Smartphone App Reveals Erratic Diurnal Eating Patterns in Humans That Can Be Modulated for Health Benefits”. Cell Metabolism. Elsevier BV. doi:10.1016/j.cmet.2015.09.005.
- Peek, Clara B., Kathryn M. Ramsey, Biliana Marcheva, and Joseph Bass. 2012. “Nutrient Sensing and the Circadian Clock”. Trends in Endocrinology & Metabolism. Elsevier BV. doi:10.1016/j.tem.2012.02.003.
- Zarrinpar, Amir, Amandine Chaix, and Satchidananda Panda. 2016. “Daily Eating Patterns and Their Impact on Health and Disease”. Trends in Endocrinology & Metabolism. Elsevier BV. doi:10.1016/j.tem.2015.11.007.
- Leproult, Rachel, Ulf Holmbäck, and Eve Van Cauter. 2014. “Circadian Misalignment Augments Markers of Insulin Resistance and Inflammation, Independently of Sleep Loss”. Diabetes. American Diabetes Association. doi:10.2337/db13-1546.
- Grimaldi, Daniela, Jason R. Carter, Eve Van Cauter, and Rachel Leproult. 2016. “Adverse Impact of Sleep Restriction and Circadian Misalignment on Autonomic Function in Healthy Young Adults”. Hypertension. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/hypertensionaha.115.06847.
- Arble, Deanna Marie, Kathryn Moynihan Ramsey, Joseph Bass, and Fred W. Turek. 2010. “Circadian Disruption and Metabolic Disease: Findings from Animal Models”. Best Practice & Research Clinical Endocrinology & Metabolism. Elsevier BV. doi:10.1016/j.beem.2010.08.003.
- Gerhart-Hines, Zachary, and Mitchell A. Lazar. 2015. “Circadian Metabolism in the Light of Evolution”. Endocrine Reviews. The Endocrine Society. doi:10.1210/er.2015-1007.
- McHill, Andrew W., Edward L. Melanson, Janine Higgins, Elizabeth Connick, Thomas M. Moehlman, Ellen R. Stothard, and Kenneth P. Wright Jr.. 2014. “Impact of Circadian Misalignment on Energy Metabolism During Simulated Nightshift Work”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1412021111.
- Arble, Deanna M., Joseph Bass, Cecilia Diniz Behn, Matthew P. Butler, Etienne Challet, Charles Czeisler, Christopher M. Depner, et al.. 2015. “Impact of Sleep and Circadian Disruption on Energy Balance and Diabetes: A Summary of Workshop Discussions”. Sleep. Oxford University Press (OUP). doi:10.5665/sleep.5226.
- Morris, Christopher J., Jessica N. Yang, Joanna I. Garcia, Samantha Myers, Isadora Bozzi, Wei Wang, Orfeu M. Buxton, Steven A. Shea, and Frank A. J. L. Scheer. 2015. “Endogenous Circadian System and Circadian Misalignment Impact Glucose Tolerance via Separate Mechanisms in Humans”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1418955112.
- Morris, Christopher J., Joanna I. Garcia, Samantha Myers, Jessica N. Yang, Noortje Trienekens, and Frank A.J.L. Scheer. 2015. “The Human Circadian System Has a Dominating Role in Causing the Morning/evening Difference in Diet-induced Thermogenesis”. Obesity. Wiley. doi:10.1002/oby.21189.
- Morris, Christopher J., Taylor E. Purvis, Joseph Mistretta, and Frank A. J. L. Scheer. 2016. “Effects of the Internal Circadian System and Circadian Misalignment on Glucose Tolerance in Chronic Shift Workers”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2015-3924.
- Buxton, Orfeu M., Sean W. Cain, Shawn P. O’Connor, James H. Porter, Jeanne F. Duffy, Wei Wang, Charles A. Czeisler, and Steven A. Shea. 2012. “Adverse Metabolic Consequences in Humans of Prolonged Sleep Restriction Combined with Circadian Disruption”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.3003200.
- Dibner, C., and U. Schibler. 2015. “Circadian Timing of Metabolism in Animal Models and Humans”. Journal of Internal Medicine. Wiley. doi:10.1111/joim.12347.
- Summa, Keith C., and Fred W. Turek. 2014. “Chronobiology and Obesity: Interactions Between Circadian Rhythms and Energy Regulation”. Advances in Nutrition. Oxford University Press (OUP). doi:10.3945/an.113.005132.
- Maury, E., H.K. Hong, and J. Bass. 2014. “Circadian Disruption in the Pathogenesis of Metabolic Syndrome”. Diabetes & Metabolism. Elsevier BV. doi:10.1016/j.diabet.2013.12.005.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2018. "Behavioral Chronotype: Impact on Sleep and Metabolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03647306.
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