An interventional study of 3 standard meals/day and 2 meals/day (omit breakfast) in Skipping Breakfast and Circadian Rhythms, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-26.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Basic science
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).
Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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)
Determine the effect of skipping breakfast on basal adipose tissue lipolytic activity and skeletal muscle insulin sensitivity
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.
Time frame: 3 weeks
Determine the effect of skipping breakfast on 24-hour plasma substrate, hormone concentrations and intramyocellular fatty acid mediators of lipotoxicity.
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.
Time frame: 3 weeks
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.
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 \[cluster of differentiation 36(CD36), uncoupling protein 3 (UCP3) and pyruvate dehydrogenase kinase, isozyme 4(PDK4)\].
Time frame: 3 weeks
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Washington University School of Medicine