Breakfast Consumption and Energy Balance in Active Adult Males

September 6, 2023 updated by: Angela Hillman, Ohio University

Comparison of Fasted vs. Carbohydrate and Protein Breakfast on Exercise Metabolism and Rest of the Day Energy Intake

Exercising in the fasted state results in greater fat oxidation during exercise and results in decreased caloric intake in the meals after exercise. However, the studies that examine fasted vs. fed exercise utilize a carbohydrate-based breakfast, which can increase blood glucose and insulin concentrations, which is considered a negative consequence. A protein breakfast, which can increase satiety and rest of day energy intake could also increase resting energy expenditure as well as fat oxidation during exercise. However, comparisons between fasting exercise and pre-exercise breakfast macronutrient intake (i.e., carbohydrate vs. protein) have not been made. Therefore the purpose of this study is to investigate if eating breakfast and the composition of this breakfast before exercise has an effect on the food eaten throughout the rest of the day.

Study Overview

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Athens, Ohio, United States, 45701
        • Ohio University Exercise Physiology Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-45 years old
  • regularly participate in exercise for at least 150 min per week
  • run at least 3 days per week for 30 minutes
  • able to complete a VO2max test
  • able to exercise for 45 min moderate intensity exercise at one time without breaks

Exclusion Criteria:

  • not participating in structured exercise of 150 min/week for the past 6 months
  • not running at least 3 days per week for 30 minutes
  • not attaining a VO2max of 50 ml/kg/min (60th percentile fitness classification according to the American College of Sports Medicine)
  • currently smoke or quit smoking less than one year ago.
  • diagnosed with or are being treated for a cardiovascular disease, high blood pressure, fibromyalgia, irritable bowel syndrome or a metabolic disorder such as diabetes, thyroid disorder, or high cholesterol.
  • food allergies or sensitivities.
  • not willing to have blood drawn on 4 occasions during each trial (16 total times)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbohydrate-based breakfast + exercise
maltodextrin
maltodextrin (25g in 12 oz water) 1 hour pre-exercise
maltodextrin (25g in 12 oz water) with no exercise
Experimental: Protein-based breakfast + exercise
whey
whey (25g in 12 oz water) 1 hour pre-exercise
Experimental: Fasted breakfast + exercise
water
non-caloric control (12 oz flavored water) 1 hour pre-exercise
Sham Comparator: Carbohydrate-based breakfast + no exercise
maltodextrin
maltodextrin (25g in 12 oz water) 1 hour pre-exercise
maltodextrin (25g in 12 oz water) with no exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in energy expenditure
Time Frame: immediately pre-breakfast, immediately post-breakfast, immediately pre-exercise, and immediately post-exercise
Measured via indirect calorimetry
immediately pre-breakfast, immediately post-breakfast, immediately pre-exercise, and immediately post-exercise
Change in lunch energy intake
Time Frame: 60 min post-exercise
measured via standardized lunch buffet
60 min post-exercise
Change in dinner energy intake
Time Frame: Day 1 (trial 1); between Days 6 and 8 (trial 2); between Days 11 and 15 (trial 3); and between Days 16 and 22 (trial 4)
weight of food returned the following day
Day 1 (trial 1); between Days 6 and 8 (trial 2); between Days 11 and 15 (trial 3); and between Days 16 and 22 (trial 4)
Change in appetite
Time Frame: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, and immediately pre-lunch
measured via circulating hormones
immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, and immediately pre-lunch
Change in blood glucose
Time Frame: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, and immediately pre-dinner
measured via fingerstick blood assessment
immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, and immediately pre-dinner
Change in subjective hunger
Time Frame: baseline, immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, immediately post-lunch, immediately pre-dinner, and immediately post-dinner
measured via 100mm visual analogue scale, higher scores indicate greater hunger
baseline, immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, immediately post-lunch, immediately pre-dinner, and immediately post-dinner

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Actual)

August 27, 2021

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20-F-9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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