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Completed

NCT Number: NCT04862208

Breakfast Consumption and Energy Balance in Active Adult Males

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.

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Key information

Conditions

Energy Intake Hormones Satiety Substrate Utilization

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University Exercise Physiology Lab

Athens, Ohio, 45701, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Maltodextrin supplement

Dietary Supplement

maltodextrin (25g in 12 oz water) 1 hour pre-exercise

Whey supplement

Dietary Supplement

whey (25g in 12 oz water) 1 hour pre-exercise

Water

Dietary Supplement

non-caloric control (12 oz flavored water) 1 hour pre-exercise

Primary outcomes

  1. Change in energy expenditure

    Time frame: immediately pre-breakfast, immediately post-breakfast, immediately pre-exercise, and immediately post-exercise

    Measured via indirect calorimetry

  2. Change in lunch energy intake

    Time frame: 60 min post-exercise

    measured via standardized lunch buffet

  3. 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

  4. Change in appetite

    Time frame: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, and immediately pre-lunch

    measured via circulating hormones

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Apr 27, 2021
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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