Breakfast Consumption and Energy Balance in Active Adult Males

Satiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862208
• Other study ID #: 20-F-9
• Status: Completed
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: September 2023
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 1, 2023
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Energy Intake
• Hormones
• Satiety
• Substrate Utilization

Intervention

Dietary Supplement:
• Maltodextrin supplement
maltodextrin (25g in 12 oz water) 1 hour pre-exercise
• Whey supplement
whey (25g in 12 oz water) 1 hour pre-exercise
• Water
non-caloric control (12 oz flavored water) 1 hour pre-exercise
• Maltodextrin supplement
maltodextrin (25g in 12 oz water) with no exercise

Locations

Country	Name	City	State
United States	Ohio University Exercise Physiology Lab	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in energy expenditure	Measured via indirect calorimetry	immediately pre-breakfast, immediately post-breakfast, immediately pre-exercise, and immediately post-exercise
Primary	Change in lunch energy intake	measured via standardized lunch buffet	60 min post-exercise
Primary	Change in dinner energy intake	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)
Primary	Change in appetite	measured via circulating hormones	immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, and immediately pre-lunch
Primary	Change in blood glucose	measured via fingerstick blood assessment	immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, and immediately pre-dinner
Primary	Change in subjective hunger	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