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White Adipose Tissue Clocks and High Calorie Feeding

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ClinicalTrials.gov Identifier: NCT02809482
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Peripheral tissues (e.g. liver, adipose, muscle) express self-sustained circadian clocks that coordinate daily metabolic rhythms. The timing of clock rhythms in peripheral tissues is highly sensitive to feeding-fasting signals across the sleep-wake transition. Nutritional insults such as high fat overfeeding (HF-OF) have been shown to attenuate clock gene expression in peripheral tissues resulting in a deleterious re-programming of the circadian metabolome. Studies in humans have only superficially investigated how the circadian clock machinery is impacted by nutritional signals. The overall goal of this pilot project is to take the first steps toward developing translational methods to investigate links between changes in energy flux and the circadian system in human tissues. Using an innovative ex vivo cell culture approach the investigators will examine the impact of 3-days of HF-OF compared to eucaloric (EU) feeding on the expression of core clock genes in human subcutaneous adipose tissue (SAT). The Investigators hypothesize that compared to EU, the amplitude of clock gene expression in SAT measured over 24hrs will be attenuated following short-term HF-OF. This pilot project will serve as a launch point for designing future studies into the effects of diet and exercise on the circadian control of metabolism in adipose tissue depots as well as other tissues (e.g. muscle).

Condition or disease Intervention/treatment Phase
Healthy Other: Eucaloric feeding Other: Overfeeding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study to Examine the Impact of Overfeeding on Peripheral Clock Gene Expression in Humans
Actual Study Start Date : July 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Eucaloric Feeding Other: Eucaloric feeding
3 days of a diet designed to maintain energy balance

Overfeeding Other: Overfeeding
3 days of a diet designed to induce a 40% positive energy balance




Primary Outcome Measures :
  1. Expression of clock genes in adipose tissue. [ Time Frame: Measured through study completion, an average of 4 weeks. ]
    Gene expression measured at two time points from abdominal fat.


Secondary Outcome Measures :
  1. Gene expression of key cellular fuel sensors thought to be controlled. and/or influenced by peripheral clocks [ Time Frame: Measured through study completion, an average of 4 weeks. ]
    Gene expression measured at two time points from abdominal fat.

  2. Expression of clock genes in blood monocytes. [ Time Frame: Measured through study completion, an average of 4 weeks. ]
    Gene expression measured at two time points from abdominal fat.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • males and females aged 20-35 yr;
  • 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:

  • Smoker (current or within the previous 3 months);
  • 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).

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): NCT02809482


Locations
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United States, Colorado
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Daniel Bessesen, MD University of Colorado School of Medicine
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02809482    
Other Study ID Numbers: 15-1570
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Volunteers