MetabolismNCT06407050
Duration of Physical Inactivity and Postprandial Lipid Metabolism
A study testing 4 hours of physical inactivity, 8 hours of physical inactivity and 12 hours of physical inactivity in people with Metabolism, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of the study is to investigate the effect of different periods of physical inactivity on postprandial lipid metabolism in the morning after exercise by measuring plasma triglyceride levels and fat oxidation (burning). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism
- What is being tested?
- 4 hours of physical inactivity, 8 hours of physical inactivity and 12 hours of physical inactivity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Nov 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female between the age of 18-40 years old
- Untrained or recreationally active
- No metabolic disease, no lactose intolerance, not taking medicines altering lipid or carbohydrate metabolism
- No injury or disease affecting the cycling ability.
Who cannot join
- On medications that alter lipid or carbohydrate metabolism lactose intolerant
- General health problems: Heart problems or coronary artery disease, hypertension, lung or respiratory problems.
- Exercise problems: Chest pain, fainting, palpitations, told to give up sports because of health problems.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: Effect of the Physical Inactivity Durations During the Day on Postprandial Lipid Metabolism the Morning After Exercise
The purpose of the study is to investigate the effect of different periods of physical inactivity on postprandial lipid metabolism in the morning after exercise by measuring plasma triglyceride levels and fat oxidation (burning). The study is a crossover intervention with all healthy participants performing three trials varying in length of physical inactive (4 hours, 8 hours, and 12 hours). All trials include a physical activity control phase (\>8,500 steps/24hr), a physical inactive phase, a moderate intensity cycling session, and a high-fat tolerance test.
Read the detailed description
This study investigates the effect of the length of physical inactivity during the day on postprandial lipid metabolism the following morning after exercise. Three intervention trials differentiate with different periods of physical inactivity (4 hours, 8 hours, and 12 hours) will be involved for this purpose. The study aims to determine how long a period of physical inactivity will diminish the exercise improved fat metabolism after meal.
12 male and female participants will be recruited from Austin community to participate this study. All participants will self-report that they have been medically cleared for exercise by submitting a health history questionnaire. Researchers will screen all forms filled out by participants and confirm that participants are eligible for this study. Participants will receive both written and verbal descriptions of the study procedures and measurements, and provide written informed consent.
The study requires at least 7 visits besides the day for questionnaire filling and informed consent signing. One for incremental exercise test, and 6 for the three trials (one cycling session and one high fat tolerance tests for each trial). All visits will take place in the Human Performance Lab at the University of Texas at Austin. All participants will complete the incremental exercise test on a stationary bike (cycle ergometer) before three intervention trials in a randomized order.
During the incremental exercise test, participant will cycling on a cycle ergometer with a mask. Participant\'s breathing air will go through the tubes connecting with the mask. By analyzing the exhaled gas during the test, the maximal oxygen consumption (VO2max) will be measured for determining the cycling intensity for the cycling in the three trials. Between trials, there will be a washout period of at least five days. The three trials varies in length of physical inactive (4 hours, 8 hours, and 12 hours) during the day. Thus, the three trials are marked as 4-hr trial, 8-hr trial, and 12-hr trial. During the cycling sessions, participant will cycle for 1 hour at an intensity of 60-65% of VO2max (moderate intensity) on a cycling ergometer. The high fat tolerance test (HFTT) day will be the day for collecting primary data.
To highlight the effect of physical inactivity duration on causing exercise resistance, all HFTT will start at the same time on the testing day of each trial, which is 9 am on the final day of each trial. For easier understanding, the events sequence in each of the trails is listed below,
- One day for participant\'s routine steps counts and sleep hours monitor.
- A 48 hours of physical activity control phase (\> 8,500 steps/24hr).
- On the third day, a physical inactivity intervention will be done either from 4 pm - 8 pm (4-hr trial), 12 pm - 8 pm (8-hour trial), or 8 am - 8 pm (12 hour trial). Hourly 600 steps will be done from the morning until the inactivity intervention starts. A 1-hr cycling session from 8 pm to 9 pm.
- A HFTT from 9 am to 2 pm on the last day of each trial.
During the whole trials, participants will be given a Fitbit wristband and a pedometer for step counts control and sleep hours record. A three day food log will be provided to participants in all trials and will be returned after each trial. A standard frozen meal will be provided to the participants to consume 2 hours before the cycling sessions to avoid the effect from fat consumption from the meal before the HFTT. Other than the sport drink that will be provided right after the cycling, participants will need to stay fasted (no food or beverage, only water) since the frozen meal to the HFTT. During the HFTT, a high fat meal (a mixture of ice cream and heavy cream) will be provided to participants. Participants will consume the milkshake in 10 min. The amount of ice cream and heavy cream will be determined by participant\'s body weight. During the test, five measurements (fingertip blood collection and exhaled air collection) will be done including one baseline measurement (before high fat meal), and four measurements each hour after consuming the meal.
- Conditions
- Metabolism
- Being tested
- 4 hours of physical inactivity, 8 hours of physical inactivity, 12 hours of physical inactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 hours of physical inactivityBehavioural
A pedometer will be worn by participants during the whole trial. Steps will be monitored. Participants will be required to reach 8,500 steps per day for the first 2 days. On the third day participants need to take 600 steps hourly for 8 hours from 7 am to 3 pm and another 2,000 steps between 3:40 pm to 4 pm. Participant will then stay inactive from 4 pm to 8 pm and do a cycling for one hour in the lab. During the inactivity period, participants will remain seated and steps are only allowed for food, water, and bathroom use. A 3 day food log will be given to participants to log in their diet. Participant will be asks to mimic the diet between trials. A Fitbit will be worn by participants to record the sleep hours during the trial.
8 hours of physical inactivityBehavioural
A pedometer will be worn by participants during the whole trial. Steps will be monitored. Participants will be required to reach 8,500 steps per day for the first 2 days. On the third day participants need to take 600 steps hourly for 4 hours from 7 am to 11 am and then 2,000 steps between 11:40 am to 12 pm. During the inactivity period, participants will remain seated and steps are only allowed for food, water, and bathroom use. Participant will then stay inactive from 12 pm to 8 pm and do a cycling for one hour in the lab. A 3 day food log will be given to participants to log in their diet. Participant will be asks to mimic the diet between trials. A Fitbit will be worn by participants to record the sleep hours during the trial.
12 hours of physical inactivityBehavioural
A pedometer will be worn by participants during the whole trial. Steps will be monitored. Participants will be required to reach 8,500 steps per day for the first 2 days. On the third day, participant will take 2,000 steps between 7:40 am to 8 am and then stay inactive from 8 am to 8 pm. During the inactivity period, participants will remain seated and steps are only allowed for food, water, and bathroom use. Right after the inactivity intervention, participant will do a 1-hr cycling in lab. A 3 day food log will be given to participants to log in their diet. Participant will be asks to mimic the diet between trials. A Fitbit will be worn by participants to record the sleep hours during the trial.
| Study group | Role | What they receive |
|---|---|---|
| 4-hr trial | Experimental | Participants will go through a day of routine step counts and sleep hour monitor, 2 days of being physical active by taking ambulatory steps, 4 hours of physical inactivity intervention, and moderate intensity cycling, and 1 high fat tolerance test. Receives: Behavioral: 4 hours of physical inactivity |
| 8-hr Trial | Experimental | Participants will go through a day of routine step counts and sleep hour monitor, 2 days of being physical active by taking ambulatory steps, 8 hours of physical inactivity intervention, and moderate intensity cycling, and 1 high fat tolerance test. Receives: Behavioral: 8 hours of physical inactivity |
| 12-hr Trial | Experimental | Participants will go through a day of routine step counts and sleep hour monitor, 2 days of being physical active by taking ambulatory steps, 12 hours of physical inactivity intervention, and moderate intensity cycling, and 1 high fat tolerance test. Receives: Behavioral: 12 hours of physical inactivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat oxidation (fat burning)
Exhaled gas will be collected during the high fat tolerance test. Fat oxidation will be calculated based on the gas volume and CO2 and O2 proportion.
Measured: Through study completion, around 9 months
Plasma triglyceride
Fingertip blood will be collected during the high fat tolerance test.
Measured: Through study completion, around 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Apr 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MetabolismStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407050
- Sponsor's protocol ID
- STUDY00005669
- Status last verified
- Feb 2025
- First submitted
- 6 May 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coyle EF, Burton HM, Satiroglu R. Inactivity Causes Resistance to Improvements in Metabolism After Exercise. Exerc Sport Sci Rev. 2022 Apr 1;50(2):81-88. doi: 10.1249/JES.0000000000000280.
PubMed 35025844
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Physical Inactivity Durations During the Day on Postprandial Lipid Metabolism the Morning After Exercise
- ClinicalTrials.gov ID
- NCT06407050
- Acronym / sponsor ID
- STUDY00005669
- Conditions
- Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 9 May 2024 (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.
The purpose of the study is to investigate the effect of different periods of physical inactivity on postprandial lipid metabolism in the morning after exercise by measuring plasma triglyceride levels and fat oxidation (burning). The study is a crossover intervention with all healthy participants performing three trials varying in length of physical inactive (4 hours, 8 hours, and 12 hours). All trials include a physical activity control phase (\>8,500 steps/24hr), a physical inactive phase, a moderate intensity cycling session, and a high-fat tolerance test.
Detailed description
This study investigates the effect of the length of physical inactivity during the day on postprandial lipid metabolism the following morning after exercise. Three intervention trials differentiate with different periods of physical inactivity (4 hours, 8 hours, and 12 hours) will be involved for this purpose. The study aims to determine how long a period of physical inactivity will diminish the exercise improved fat metabolism after meal.
12 male and female participants will be recruited from Austin community to participate this study. All participants will self-report that they have been medically cleared for exercise by submitting a health history questionnaire. Researchers will screen all forms filled out by participants and confirm that participants are eligible for this study. Participants will receive both written and verbal descriptions of the study procedures and measurements, and provide written informed consent.
The study requires at least 7 visits besides the day for questionnaire filling and informed consent signing. One for incremental exercise test, and 6 for the three trials (one cycling session and one high fat tolerance tests for each trial). All visits will take place in the Human Performance Lab at the University of Texas at Austin. All participants will complete the incremental exercise test on a stationary bike (cycle ergometer) before three intervention trials in a randomized order.
During the incremental exercise test, participant will cycling on a cycle ergometer with a mask. Participant\'s breathing air will go through the tubes connecting with the mask. By analyzing the exhaled gas during the test, the maximal oxygen consumption (VO2max) will be measured for determining the cycling intensity for the cycling in the three trials. Between trials, there will be a washout period of at least five days. The three trials varies in length of physical inactive (4 hours, 8 hours, and 12 hours) during the day. Thus, the three trials are marked as 4-hr trial, 8-hr trial, and 12-hr trial. During the cycling sessions, participant will cycle for 1 hour at an intensity of 60-65% of VO2max (moderate intensity) on a cycling ergometer. The high fat tolerance test (HFTT) day will be the day for collecting primary data.
To highlight the effect of physical inactivity duration on causing exercise resistance, all HFTT will start at the same time on the testing day of each trial, which is 9 am on the final day of each trial. For easier understanding, the events sequence in each of the trails is listed below,
- One day for participant\'s routine steps counts and sleep hours monitor.
- A 48 hours of physical activity control phase (\> 8,500 steps/24hr).
- On the third day, a physical inactivity intervention will be done either from 4 pm - 8 pm (4-hr trial), 12 pm - 8 pm (8-hour trial), or 8 am - 8 pm (12 hour trial). Hourly 600 steps will be done from the morning until the inactivity intervention starts. A 1-hr cycling session from 8 pm to 9 pm.
- A HFTT from 9 am to 2 pm on the last day of each trial.
During the whole trials, participants will be given a Fitbit wristband and a pedometer for step counts control and sleep hours record. A three day food log will be provided to participants in all trials and will be returned after each trial. A standard frozen meal will be provided to the participants to consume 2 hours before the cycling sessions to avoid the effect from fat consumption from the meal before the HFTT. Other than the sport drink that will be provided right after the cycling, participants will need to stay fasted (no food or beverage, only water) since the frozen meal to the HFTT. During the HFTT, a high fat meal (a mixture of ice cream and heavy cream) will be provided to participants. Participants will consume the milkshake in 10 min. The amount of ice cream and heavy cream will be determined by participant\'s body weight. During the test, five measurements (fingertip blood collection and exhaled air collection) will be done including one baseline measurement (before high fat meal), and four measurements each hour after consuming the meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4-hr trial | Experimental | Behavioral: 4 hours of physical inactivityParticipants will go through a day of routine step counts and sleep hour monitor, 2 days of being physical active by taking ambulatory steps, 4 hours of physical inactivity intervention, and moderate intensity cycling, and 1 high fat tolerance test. |
| 8-hr Trial | Experimental | Behavioral: 8 hours of physical inactivityParticipants will go through a day of routine step counts and sleep hour monitor, 2 days of being physical active by taking ambulatory steps, 8 hours of physical inactivity intervention, and moderate intensity cycling, and 1 high fat tolerance test. |
| 12-hr Trial | Experimental | Behavioral: 12 hours of physical inactivityParticipants will go through a day of routine step counts and sleep hour monitor, 2 days of being physical active by taking ambulatory steps, 12 hours of physical inactivity intervention, and moderate intensity cycling, and 1 high fat tolerance test. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female between the age of 18-40 years old
- Untrained or recreationally active
- No metabolic disease, no lactose intolerance, not taking medicines altering lipid or carbohydrate metabolism
- No injury or disease affecting the cycling ability.
Key exclusion criteria (3 listed)
- On medications that alter lipid or carbohydrate metabolism lactose intolerant
- General health problems: Heart problems or coronary artery disease, hypertension, lung or respiratory problems.
- Exercise problems: Chest pain, fainting, palpitations, told to give up sports because of health problems.
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 |
|---|---|---|
| 4 hours of physical inactivityA pedometer will be worn by participants during the whole trial. Steps will be monitored. Participants will be required to reach 8,500 steps per day for the first 2 days. On the third day participants need to take 600 steps hourly for 8 hours from 7 am to 3 pm and another 2,000 steps between 3:40 pm to 4 pm. Participant will then stay inactive from 4 pm to 8 pm and do a cycling for one hour in the lab. During the inactivity period, participants will remain seated and steps are only allowed for food, water, and bathroom use. A 3 day food log will be given to participants to log in their diet. Participant will be asks to mimic the diet between trials. A Fitbit will be worn by participants to record the sleep hours during the trial. | Behavioural | 4-hr trial |
| 8 hours of physical inactivityA pedometer will be worn by participants during the whole trial. Steps will be monitored. Participants will be required to reach 8,500 steps per day for the first 2 days. On the third day participants need to take 600 steps hourly for 4 hours from 7 am to 11 am and then 2,000 steps between 11:40 am to 12 pm. During the inactivity period, participants will remain seated and steps are only allowed for food, water, and bathroom use. Participant will then stay inactive from 12 pm to 8 pm and do a cycling for one hour in the lab. A 3 day food log will be given to participants to log in their diet. Participant will be asks to mimic the diet between trials. A Fitbit will be worn by participants to record the sleep hours during the trial. | Behavioural | 8-hr Trial |
| 12 hours of physical inactivityA pedometer will be worn by participants during the whole trial. Steps will be monitored. Participants will be required to reach 8,500 steps per day for the first 2 days. On the third day, participant will take 2,000 steps between 7:40 am to 8 am and then stay inactive from 8 am to 8 pm. During the inactivity period, participants will remain seated and steps are only allowed for food, water, and bathroom use. Right after the inactivity intervention, participant will do a 1-hr cycling in lab. A 3 day food log will be given to participants to log in their diet. Participant will be asks to mimic the diet between trials. A Fitbit will be worn by participants to record the sleep hours during the trial. | Behavioural | 12-hr Trial |
Primary outcome
Fat oxidation (fat burning)
Time frame: Through study completion, around 9 months
Exhaled gas will be collected during the high fat tolerance test. Fat oxidation will be calculated based on the gas volume and CO2 and O2 proportion.
Plasma triglyceride
Time frame: Through study completion, around 9 months
Fingertip blood will be collected during the high fat tolerance test.
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 3 Mar 2025.
- Background: PubMed 35025844Coyle EF, Burton HM, Satiroglu R. Inactivity Causes Resistance to Improvements in Metabolism After Exercise. Exerc Sport Sci Rev. 2022 Apr 1;50(2):81-88. doi: 10.1249/JES.0000000000000280.
- 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 4 hours of physical inactivity, 8 hours of physical inactivity and 12 hours of physical inactivity in people with Metabolism, run by University of Texas at Austin 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 4 inclusion and 3 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 3 Mar 2025. 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. 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?
Fat oxidation (fat burning) (time frame: Through study completion, around 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06407050, which also lists 1 linked publication.
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 3 Mar 2025.