Metabolic HealthNCT05291065
Breakfast, Exercise and Metabolic Health in Healthy Men
A study testing Fasted exercise, High protein breakfast exercise and High carbohydrate breakfast exercise in people with Metabolic Health and Appetitive Behavior, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
This project aims to investigate the impact of acute bout of submaximal exercise under different pre-exercise dietary conditions (fasted state versus high carbohydrate breakfast versus high protein breakfast) on postprandial glycaemic, appetite regulation and energy balance. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Health, Appetitive Behavior, Energy Balance
- What is being tested?
- Fasted exercise, High protein breakfast exercise and High carbohydrate breakfast exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Mar 2022to 1 Jan 2024
- 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy physical active men (self-reported regular exercise at least 30 min moderate-intensity 3 times per week)
- Aged between 30 to 55 years
- Weight stable for more than 3 months (no change in weight +/- 3%)
- Non-smoker
Who cannot join
- Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function
- Women
- Physically inactive
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan Normal University
Taipei
Yung-Chih Chen, PhD, yc.chen@ntnu.edu.tw
About this study
Official title: Impact of Different Pre-exercise Breakfast Composition on Post-exercise Glycaemic Response, Appetite and Energy Balance
This project aims to investigate the impact of acute bout of submaximal exercise under different pre-exercise dietary conditions (fasted state versus high carbohydrate breakfast versus high protein breakfast) on postprandial glycaemic, appetite regulation and energy balance.
Read the detailed description
Participants will be asked to arrive to the laboratory between 08:00 and 9:00 am after not eating for between 12-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Participants will then be given one of three test drinks (i.e., breakfast): 1) water only; 2) high carbohydrate drink; or 3) high protein (whey protein) drink. Each of these drinks will also contain 500 mL of water and artificial sweetener. 2 h after breakfast, participants will then exercise on a treadmill for 45 min followed by a 2-h oral glucose tolerance test (OGTT) and 30 min ad libitum lunch intake. Blood samples, blood pressures and questionnaire (e.g., appetite and mood) will be collected in a regular pattern throughout the trials. Cognitive functions will be tested at baseline, pre-exercise and 2 h post-exercise. Energy balance will be assessed using food diary and an accelerometer for the rest of the day after leaving the laboratory until midnight.
- Conditions
- Metabolic Health, Appetitive Behavior, Energy Balance
- Being tested
- Fasted exercise, High protein breakfast exercise, High carbohydrate breakfast exercise
- Keywords
- High protein breakfast, postprandial glycaemia, Appetite, Energy balance
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasted exerciseBehavioural
Participants will remain fast (Fasted) 2 h prior to 45 min exercise at 65% VO2max.
High protein breakfast exerciseBehavioural
Participants will consume a high protein breakfast (Protein) 2 h prior to 45 min exercise at 65% VO2max.
High carbohydrate breakfast exerciseBehavioural
Participants will consume a high carbohydrate breakfast (Carbohydrate) 2 h prior to 45 min exercise at 65% VO2max.
| Study group | Role | What they receive |
|---|---|---|
| Fasted exercise | Experimental | Fasted prior to exercise Receives: Behavioral: Fasted exercise |
| High protein breakfast exercise | Experimental | High protein breakfast consumption prior to exercise Receives: Behavioral: High protein breakfast exercise |
| High carbohydrate breakfast exercise | Experimental | High carbohydrate breakfast consumption prior to exercise Receives: Behavioral: High carbohydrate breakfast exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic health
Changes in blood glycaemic and insulinaemic responses post-exercise between trials
Measured: 150 minutes
Secondary outcomes (9)
Lipid profile
Changes in blood triglycerides, cholesterol \& NEFA concentrations post-exercise between trials
Measured: 150 minutes
Gut hormones
Changes in gut hormones (e.g., GLP-1, PYY and GIP, etc.) responses post-exercise between trials
Measured: 150 minutes
Appetite
ad libitum lunch intake after OGTT between trials
Measured: 30 minutes
Visual analogue scale (VSA)
Changes in VSA (e.g., appetite \& mood, etc) between trials
Measured: 305 minutes
Substrate oxidation
Changes in total energy expenditure, lipid oxidation and carbohydrate oxidation between trials
Measured: 305 minutes
Inflammation
Changes in inflammation biomarkers (e.g., IL-6, IL-10 and IL-1ra, etc.) responses during trials
Measured: 305 minutes
Blood pressure
Changes in blood pressure during trials
Measured: 305 minutes
Cognition
Changes in cognitive performance during trials
Measured: 305 minutes
Energy balance
Changes in energy intake and physical activity once participants leaving the laboratory until midnight
Measured: 480 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start13 Mar 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic HealthStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Chih Chen, National Taiwan Normal University
- Investigators
- Chen, PhD, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291065
- Sponsor's protocol ID
- 202012HM031
- Status last verified
- Apr 2023
- First submitted
- 14 Mar 2022
- Last updated
- 5 Apr 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Pre-exercise Breakfast Composition on Post-exercise Glycaemic Response, Appetite and Energy Balance
- ClinicalTrials.gov ID
- NCT05291065
- Acronym / sponsor ID
- 202012HM031
- Conditions
- Metabolic Health, Appetitive Behavior, Energy Balance
- Keywords
- High protein breakfast, postprandial glycaemia, Appetite, Energy balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 13 Mar 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 22 Mar 2022 (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.
This project aims to investigate the impact of acute bout of submaximal exercise under different pre-exercise dietary conditions (fasted state versus high carbohydrate breakfast versus high protein breakfast) on postprandial glycaemic, appetite regulation and energy balance.
Detailed description
Participants will be asked to arrive to the laboratory between 08:00 and 9:00 am after not eating for between 12-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Participants will then be given one of three test drinks (i.e., breakfast): 1) water only; 2) high carbohydrate drink; or 3) high protein (whey protein) drink. Each of these drinks will also contain 500 mL of water and artificial sweetener. 2 h after breakfast, participants will then exercise on a treadmill for 45 min followed by a 2-h oral glucose tolerance test (OGTT) and 30 min ad libitum lunch intake. Blood samples, blood pressures and questionnaire (e.g., appetite and mood) will be collected in a regular pattern throughout the trials. Cognitive functions will be tested at baseline, pre-exercise and 2 h post-exercise. Energy balance will be assessed using food diary and an accelerometer for the rest of the day after leaving the laboratory until midnight.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fasted exercise | Experimental | Behavioral: Fasted exerciseFasted prior to exercise |
| High protein breakfast exercise | Experimental | Behavioral: High protein breakfast exerciseHigh protein breakfast consumption prior to exercise |
| High carbohydrate breakfast exercise | Experimental | Behavioral: High carbohydrate breakfast exerciseHigh carbohydrate breakfast consumption prior to exercise |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy physical active men (self-reported regular exercise at least 30 min moderate-intensity 3 times per week)
- Aged between 30 to 55 years
- Weight stable for more than 3 months (no change in weight +/- 3%)
- Non-smoker
Key exclusion criteria (4 listed)
- Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function
- Women
- Physically inactive
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 |
|---|---|---|
| Fasted exerciseParticipants will remain fast (Fasted) 2 h prior to 45 min exercise at 65% VO2max. | Behavioural | Fasted exercise |
| High protein breakfast exerciseParticipants will consume a high protein breakfast (Protein) 2 h prior to 45 min exercise at 65% VO2max. | Behavioural | High protein breakfast exercise |
| High carbohydrate breakfast exerciseParticipants will consume a high carbohydrate breakfast (Carbohydrate) 2 h prior to 45 min exercise at 65% VO2max. | Behavioural | High carbohydrate breakfast exercise |
Primary outcome
Metabolic health
Time frame: 150 minutes
Changes in blood glycaemic and insulinaemic responses post-exercise between trials
9 secondary outcomes
Lipid profile
Time frame: 150 minutes
Gut hormones
Time frame: 150 minutes
Appetite
Time frame: 30 minutes
Visual analogue scale (VSA)
Time frame: 305 minutes
Substrate oxidation
Time frame: 305 minutes
Inflammation
Time frame: 305 minutes
Blood pressure
Time frame: 305 minutes
Cognition
Time frame: 305 minutes
Energy balance
Time frame: 480 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 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.
Chen, PhD principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasted exercise, High protein breakfast exercise and High carbohydrate breakfast exercise in people with Metabolic Health and Appetitive Behavior, run by National Taiwan Normal University at 1 site in Taiwan.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 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 Taiwan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yung-Chih Chen, PhD (+886277496979, yc.chen@ntnu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic health (time frame: 150 minutes). 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 5 Apr 2023.