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Completed

NCT Number: NCT02093572

Effect of Skipping Breakfast on Metabolic Function

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).

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Key information

Conditions

Skipping Breakfast Behavior Circadian Rhythms Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Intermittent Fasting Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 <7 hours/night
  • Consume excess amounts of alcohol
  • Medications that could alter the results of this study

Treatment and study plan

3 standard meals/day

Other

2 meals/day (omit breakfast)

Other

Primary outcomes

  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)].

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2014
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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