Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2016-07-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Eucaloric Feeding
Eucaloric feeding
3 days of a diet designed to maintain energy balance
Overfeeding
Overfeeding
3 days of a diet designed to induce a 40% positive energy balance
Interventions
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Eucaloric feeding
3 days of a diet designed to maintain energy balance
Overfeeding
3 days of a diet designed to induce a 40% positive energy balance
Eligibility Criteria
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Inclusion Criteria
* BMI 25-35 kg/m2 and weight stable (±2kg in past 2mo);
* non-smoker;
* sedentary to moderately active (≤3 days of exercise per week ≤30 min of exercise per session);
* sleeping pattern of \>7 hours to 9.25 hrs of sleep/night.
* subjects will be asked to identify themselves as regular consumers of 3 balanced meals per day by answering the question: "Do you eat breakfast, lunch, and dinner on ≥ 5 days per week?"
Exclusion Criteria
* Use any medication that could affect lipid metabolism, insulin signaling, or sleep;
* Pregnant women will not be enrolled in the study;
* Have a job that involves shift work;
* Dwelling below Denver altitude (1,600 m) a year prior to testing;
* Travel across more than one time zone 3 wk before a study;
* chronic health conditions such as diabetes, hyper or hypothyroidism, renal or liver disease, anemia, or cancer;
* Regularly go to sleep after midnight;
o Subjects will be excluded if they are identified as having night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week);
* Allergy to lidocaine or similar compound;
* Have one or more of the following out-of-range values measured on a fasting blood sample:
* glucose \> 110 mg/dl,
* thyroid stimulating hormone \<0.5 or \>5.0 µU/ml.
* Subjects who may be:
* anemic (hemoglobin \< 14.5 g/dl men, \<12.3 g/dl women ),
* have abnormal liver function tests (alanine amino transferase \> 47 U/l, aspartate aminotransferase, \> 47 U/l, alkaline phosphatase \<39 or \>117 U/l) or creatinine (\>1.1 mg/dl).
20 Years
35 Years
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Daniel Bessesen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado School of Medicine
Locations
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Denver, Colorado, United States
Countries
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References
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Yoo SH, Yamazaki S, Lowrey PL, Shimomura K, Ko CH, Buhr ED, Siepka SM, Hong HK, Oh WJ, Yoo OJ, Menaker M, Takahashi JS. PERIOD2::LUCIFERASE real-time reporting of circadian dynamics reveals persistent circadian oscillations in mouse peripheral tissues. Proc Natl Acad Sci U S A. 2004 Apr 13;101(15):5339-46. doi: 10.1073/pnas.0308709101. Epub 2004 Feb 12.
Oosterman JE, Kalsbeek A, la Fleur SE, Belsham DD. Impact of nutrients on circadian rhythmicity. Am J Physiol Regul Integr Comp Physiol. 2015 Mar 1;308(5):R337-50. doi: 10.1152/ajpregu.00322.2014. Epub 2014 Dec 17.
Eckel-Mahan KL, Patel VR, de Mateo S, Orozco-Solis R, Ceglia NJ, Sahar S, Dilag-Penilla SA, Dyar KA, Baldi P, Sassone-Corsi P. Reprogramming of the circadian clock by nutritional challenge. Cell. 2013 Dec 19;155(7):1464-78. doi: 10.1016/j.cell.2013.11.034.
Pivovarova O, Jurchott K, Rudovich N, Hornemann S, Ye L, Mockel S, Murahovschi V, Kessler K, Seltmann AC, Maser-Gluth C, Mazuch J, Kruse M, Busjahn A, Kramer A, Pfeiffer AF. Changes of Dietary Fat and Carbohydrate Content Alter Central and Peripheral Clock in Humans. J Clin Endocrinol Metab. 2015 Jun;100(6):2291-302. doi: 10.1210/jc.2014-3868. Epub 2015 Mar 30.
Rynders CA, Morton SJ, Bessesen DH, Wright KP Jr, Broussard JL. Circadian Rhythm of Substrate Oxidation and Hormonal Regulators of Energy Balance. Obesity (Silver Spring). 2020 Jul;28 Suppl 1(Suppl 1):S104-S113. doi: 10.1002/oby.22816. Epub 2020 May 28.
Other Identifiers
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15-1570
Identifier Type: -
Identifier Source: org_study_id
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