Effect of Skipping Breakfast on Metabolic Function

Not Applicable

Completed

• Conditions: Skipping Breakfast; Circadian Rhythms
• Interventions: Other: 3 standard meals/day; Other: 2 meals/day (omit breakfast)

• Registration Number: NCT02093572
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-21
• Study Start: 2014-05
• Primary Completion: 2017-05-05
• Study Completion: 2017-05-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	3 standard meals/day	Subjects randomized to this group will consume 3 standard meals/day during the 2 week intervention period of the study.
Breakfast skipping	2 meals/day (omit breakfast)	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.

Primary Outcome Measures

Name	Time	Method
Determine the effect of skipping breakfast on basal adipose tissue lipolytic activity and skeletal muscle insulin sensitivity	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.
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.	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 \[cluster of differentiation 36(CD36), uncoupling protein 3 (UCP3) and pyruvate dehydrogenase kinase, isozyme 4(PDK4)\].
Determine the effect of skipping breakfast on 24-hour plasma substrate, hormone concentrations and intramyocellular fatty acid mediators of lipotoxicity.	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States