Clinical trial NCT04862208: Breakfast Consumption and Energy Balance in Active Adult Males
Official title: Comparison of Fasted vs. Carbohydrate and Protein Breakfast on Exercise Metabolism and Rest of the Day Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Intake
Substrate Utilization
Hormones
Satiety
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in energy expenditure
timeFrame: immediately pre-breakfast, immediately post-breakfast, immediately pre-exercise, and immediately post-exercise
measure: Change in lunch energy intake
timeFrame: 60 min post-exercise
measure: Change in dinner energy intake
timeFrame: 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)
measure: Change in appetite
timeFrame: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, and immediately pre-lunch
measure: Change in blood glucose
timeFrame: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, and immediately pre-dinner
measure: Change in subjective hunger
timeFrame: baseline, immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, immediately post-lunch, immediately pre-dinner, and immediately post-dinner
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University Exercise Physiology Lab
state: Ohio
Study officials:
References: