CompletedNot Applicable

Breakfast Consumption and Energy Balance in Active Adult Males

United States10 participantsStarted 2021-05-06

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in energy expenditure

Timeframe: immediately pre-breakfast, immediately post-breakfast, immediately pre-exercise, and immediately post-exercise

Change in lunch energy intake

Timeframe: 60 min post-exercise

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)

Change in appetite

Timeframe: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, and immediately pre-lunch

Change in blood glucose

Timeframe: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, and immediately pre-dinner

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

Trial details

NCT IDNCT04862208

SponsorOhio University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-27

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