Effect of Skipping Breakfast on Metabolic Function

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02093572

Collaborator

(none)

Enrollment

Location

Arms

36.1

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

Study Design

Study Type:

Interventional

Actual 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

Actual Study Start Date :

May 1, 2014

Actual Primary Completion Date :

May 5, 2017

Actual Study Completion Date :

May 5, 2017

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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 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.
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)].

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator: Jun Yoshino, MD, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT02093572

Other Study ID Numbers:

201402039
KL2TR000450

First Posted:

Mar 21, 2014

Last Update Posted:

Mar 26, 2021

Last Verified:

Mar 1, 2021

Keywords provided by Washington University School of Medicine

Clock genes

Metabolism

Insulin sensitivity

Study Results

No Results Posted as of Mar 26, 2021