Energy IntakeNCT04862208
Breakfast Consumption and Energy Balance in Active Adult Males
A study testing Maltodextrin supplement, Whey supplement and Water in people with Energy Intake and Substrate Utilization, run by Ohio University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Energy Intake, Substrate Utilization, Hormones
- What is being tested?
- Maltodextrin supplement, Whey supplement and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio University Exercise Physiology Lab
Athens, Ohio, 45701
About this study
Official title: 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.
- Conditions
- Energy Intake, Substrate Utilization, Hormones, Satiety
- Being tested
- Maltodextrin supplement, Whey supplement, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maltodextrin supplementDietary supplement
maltodextrin (25g in 12 oz water) 1 hour pre-exercise
Whey supplementDietary supplement
whey (25g in 12 oz water) 1 hour pre-exercise
WaterDietary supplement
non-caloric control (12 oz flavored water) 1 hour pre-exercise
Maltodextrin supplementDietary supplement
maltodextrin (25g in 12 oz water) with no exercise
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate-based breakfast + exercise | Experimental | maltodextrin Receives: Dietary Supplement: Maltodextrin supplement |
| Protein-based breakfast + exercise | Experimental | whey Receives: Dietary Supplement: Whey supplement |
| Fasted breakfast + exercise | Experimental | water Receives: Dietary Supplement: Water |
| Carbohydrate-based breakfast + no exercise | Sham comparator | maltodextrin Receives: Dietary Supplement: Maltodextrin supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy expenditure
Measured via indirect calorimetry
Measured: immediately pre-breakfast, immediately post-breakfast, immediately pre-exercise, and immediately post-exercise
Change in lunch energy intake
measured via standardized lunch buffet
Measured: 60 min post-exercise
Change in dinner energy intake
weight of food returned the following day
Measured: 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
measured via circulating hormones
Measured: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, and immediately pre-lunch
Change in blood glucose
measured via fingerstick blood assessment
Measured: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, and immediately pre-dinner
Change in subjective hunger
measured via 100mm visual analogue scale, higher scores indicate greater hunger
Measured: baseline, immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, immediately pre-lunch, immediately post-lunch, immediately pre-dinner, and immediately post-dinner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start6 May 2021
- Primary completion27 Aug 2021
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Hillman, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862208
- Sponsor's protocol ID
- 20-F-9
- Status last verified
- Sep 2023
- First submitted
- 13 Apr 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fasted vs. Carbohydrate and Protein Breakfast on Exercise Metabolism and Rest of the Day Energy Intake
- ClinicalTrials.gov ID
- NCT04862208
- Acronym / sponsor ID
- 20-F-9
- Conditions
- Energy Intake, Substrate Utilization, Hormones, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate-based breakfast + exercise | Experimental | Dietary Supplement: Maltodextrin supplementmaltodextrin |
| Protein-based breakfast + exercise | Experimental | Dietary Supplement: Whey supplementwhey |
| Fasted breakfast + exercise | Experimental | Dietary Supplement: Waterwater |
| Carbohydrate-based breakfast + no exercise | Sham comparator | Dietary Supplement: Maltodextrin supplementmaltodextrin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maltodextrin supplementmaltodextrin (25g in 12 oz water) 1 hour pre-exercise | Dietary supplement | Carbohydrate-based breakfast + exercise |
| Whey supplementwhey (25g in 12 oz water) 1 hour pre-exercise | Dietary supplement | Protein-based breakfast + exercise |
| Waternon-caloric control (12 oz flavored water) 1 hour pre-exercise | Dietary supplement | Fasted breakfast + exercise |
| Maltodextrin supplementmaltodextrin (25g in 12 oz water) with no exercise | Dietary supplement | Carbohydrate-based breakfast + no exercise |
Primary outcome
Change in energy expenditure
Time frame: immediately pre-breakfast, immediately post-breakfast, immediately pre-exercise, and immediately post-exercise
Measured via indirect calorimetry
Change in lunch energy intake
Time frame: 60 min post-exercise
measured via standardized lunch buffet
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
Change in appetite
Time frame: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise, and immediately pre-lunch
measured via circulating hormones
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maltodextrin supplement, Whey supplement and Water in people with Energy Intake and Substrate Utilization, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in energy expenditure (time frame: immediately pre-breakfast, immediately post-breakfast, immediately pre-exercise, and immediately post-exercise). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.