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Effect of Skipping Breakfast on Metabolic Function

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ClinicalTrials.gov Identifier: NCT02093572
Recruitment Status : Active, not recruiting
First Posted : March 21, 2014
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The purpose of this study is to test the hypothesis that the disruption of the "normal" (three meals a day) eating pattern and prolonged overnight fasting caused by skipping breakfast: i) alters the expression of specific clock genes and clock gene targets involved in regulating adipose tissue lipolysis (breakdown or destruction); ii) increases basal adipose tissue lipolytic (breakdown) activity and plasma free fatty acid (FFA) concentrations; iii) reduces skeletal muscle insulin sensitivity; and iv) increases daylong plasma glucose, FFA, and insulin concentrations. The investigator will do this by studying healthy, lean persons either randomized to consume either 3 standard meals per day or omit breakfast and consume 2 meals per day without changing daily calorie intake (skipping breakfast group).

Condition or disease Intervention/treatment Phase
Skipping Breakfast Circadian Rhythms Other: 3 standard meals/day Other: 2 meals/day (omit breakfast) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Skipping Breakfast on Metabolic Function
Study Start Date : May 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Control
Subjects randomized to this group will consume 3 standard meals/day during the 2 week intervention period of the study.
Other: 3 standard meals/day
Experimental: Breakfast skipping
Subjects randomized to this group will consume 2 meals/day (omit breakfast - with caloric intake equal to consuming 3 meals/day) during the 2 week intervention period of the study.
Other: 2 meals/day (omit breakfast)



Primary Outcome Measures :
  1. Determine the effect of skipping breakfast on basal adipose tissue lipolytic activity and skeletal muscle insulin sensitivity [ Time Frame: 3 weeks ]
    Hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopically labeled trace infusions will be conducted before and after the diet intervention to asses the changes on basal adipose tissue lipolytic activity and skeletal muscle insulin sensitivity.

  2. Determine the effect of skipping breakfast on 24-hour plasma substrate, hormone concentrations and intramyocellular fatty acid mediators of lipotoxicity. [ Time Frame: 3 weeks ]
    Multiple blood and skeletal muscle biopsy samples will be obtained during a 24-hour feeding study before and after the diet intervention to assess 24-hour plasma substrate, hormone concentrations and intramyocellular fatty acid mediators of lipotoxicity.

  3. Determine the effect of skipping breakfast on the diurnal expression of clock genes and downstream metabolic targets involved in regulating adipose tissue lipolytic activity and skeletal muscle insulin action. [ Time Frame: 3 weeks ]
    Serial biopsy samples (every 6 hours) of adipose tissue and muscle will be obtained during the 24-hour feeding study to evaluate diurnal expression patterns of i) clock genes [CLOCK, brain and muscle Arnt-like protein-1(BMAL1), period1 (PER1), period2 (PER2), and Dbp D site albumin promoter binding protein (DBP)] in adipose tissue and muscle and ii) putative downstream clock gene targets associated with lypolysis in adipose tissue [hormone-sensitive lipase(HSL) and adipocyte triglyceride lipase (ATGL)], skeletal muscle insulin action [glucose transporter type 4(GLUT4)] and skeletal muscle fatty acid metabolism [cluster of differentiation 36(CD36), uncoupling protein 3 (UCP3) and pyruvate dehydrogenase kinase, isozyme 4(PDK4)].



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males & females
  • 18-55 years old
  • BMI between 18.5 - 29.9 kg/m2
  • Sleeps 7> hours/night
  • Normally consume 3 meals/day, including breakfast

Exclusion Criteria:

  • Pregnancy, lactating or breastfeeding
  • Diabetes
  • Sleep disorders
  • Significant organ dysfunction
  • Shift or nighttime workers
  • Smokers
  • Breakfast skippers
  • People who regularly sleep less than 7 hours/night
  • Consume excess amounts of alcohol
  • Medications that could alter the results of this study

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): NCT02093572


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Jun Yoshino, MD, PhD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02093572     History of Changes
Other Study ID Numbers: 201402039
KL2TR000450 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

Keywords provided by Washington University School of Medicine:
Clock genes
Metabolism
Insulin sensitivity