Effect of Skipping Breakfast on Metabolic Function

NCT ID: NCT02093572

Last Updated: 2021-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-05-05

Brief Summary

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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

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Conditions

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Skipping Breakfast Circadian Rhythms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control

Subjects randomized to this group will consume 3 standard meals/day during the 2 week intervention period of the study.

Group Type EXPERIMENTAL

3 standard meals/day

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

2 meals/day (omit breakfast)

Intervention Type OTHER

Interventions

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3 standard meals/day

Intervention Type OTHER

2 meals/day (omit breakfast)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Yoshino, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Yamaguchi S, Moseley AC, Almeda-Valdes P, Stromsdorfer KL, Franczyk MP, Okunade AL, Patterson BW, Klein S, Yoshino J. Diurnal Variation in PDK4 Expression Is Associated With Plasma Free Fatty Acid Availability in People. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1068-1076. doi: 10.1210/jc.2017-02230.

Reference Type DERIVED
PMID: 29294006 (View on PubMed)

Other Identifiers

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KL2TR000450

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201402039

Identifier Type: -

Identifier Source: org_study_id

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