Effect of Skipping Breakfast on Metabolic Function

NCT02093572 | Completed DMC

• 2 other identifiers: 201402039KL2TR000450
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Skipping Breakfast; Circadian Rhythms

Keywords

Clock genes; Metabolism; Insulin sensitivity

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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 \[cluster of differentiation 36(CD36), uncoupling protein 3 (UCP3) and pyruvate dehydrogenase kinase, isozyme 4(PDK4)\].

  3 weeks

Study Arms (2)

Control

EXPERIMENTAL

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

Breakfast skipping

EXPERIMENTAL

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)

Interventions

3 standard meals/day OTHER

Control

2 meals/day (omit breakfast) OTHER

Breakfast skipping

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males \& females
• years old
• BMI between 18.5 - 29.9 kg/m²
• Sleeps \>7 hours/night
• Normally consume 3 meals/day, including breakfast

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 29294006 DERIVED

MeSH Terms

Conditions

Intermittent Fasting; Insulin Resistance

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jun Yoshino, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 21, 2014
• Study Start: May 1, 2014
• Primary Completion: May 5, 2017
• Study Completion: May 5, 2017
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

US (1)