- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04862208
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
Status
Completed
Conditions
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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