Hormone DisturbanceNCT05790772
Biochemical Changes in Blood Plasma After Intense Physical Exercise of Healthy Volunteers
A study testing Vigorous Exercise in people with Hormone Disturbance and Endorphin Changes, run by Touro University Nevada at 1 site in United States.
Trial summary
This study will recruit 20 male and female athletes of endurance training background. They will participate in 50 minutes of vigorous activity on a treadmill with 3 blood draws (before exercising, 50 minutes into exercising, and 30 minutes after completion of exercising). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hormone Disturbance, Endorphin Changes
- What is being tested?
- Vigorous Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 23 Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has reportedly experienced "runner's high" during vigorous exercise.
Who cannot join
- Has not reportedly experienced "runner's high" during vigorous exercise.
Trial locations and contacts
1 site in 1 country.
About this study
This study will recruit 20 male and female athletes of endurance training background. They will participate in 50 minutes of vigorous activity on a treadmill with 3 blood draws (before exercising, 50 minutes into exercising, and 30 minutes after completion of exercising). After collection of the blood samples, the results will be analyzed for extracellular vesicles and biochemical changes within said extracellular vesicles.
Read the detailed description
This study will recruit participants from the Touro University Nevada student body by placing flyers around campus and including announcements on the TUN screens. Program faculty will be encouraged to promote the study to their students through March.
20 male and female athletes who currently participate in regular endurance training will be recruited for the study. We will use men because the hormonal responses to exercise vary between men and women and is blunted at different points during the reproductive cycle. Participants recruited into the study will be normal weight (BMI or waist-to-hip ratio), and a history of regular participation in endurance training (see flyer). Participants will not have been diagnosed or treated for any psychiatric conditions, lower extremity or low back injury and will not have regularly taken any prescription medications within the past year.
Participants will be consented into the study, scheduled, and given pre-participation instructions one week prior to the event. They will not take over-the-counter medications or supplements within one week of the trial, have no alcohol within 72 hours and no caffeine or nicotine within four hours, and no food within two hours of the protocol. Participants may drink water ad libitum prior to the trial.
Upon arriving the day of the trial, participants will be screened by urinalysis for drug use. They will complete a survey based on the International Physical Activity Questionnaire which will be used to classify their history of physical activity. They will complete a pre-activity screen of their current emotional state using a set of Visual Analog Scales (VAS).
On the day of the trial, participants will provide a urine sample for urinalysis. They will complete an electronic survey on their cell phone and will complete a paper survey including a set of visual analog scales. A butterfly needle will be inserted into their arm of choice which will allow the four small (5 ml) blood samples to be drawn throughout the activity. The first sample will be drawn immediately upon inserting the needle with subsequent draws performed at 50-minutes of physical activity, and the final draw 30-minutes after the activity ends. They will wear a heart monitor that will be used to monitor exercise intensity throughout the exercise protocol.
Participants will complete an exercise protocol that includes 50 minutes of vigorous activity on a treadmill. They will be instructed to perform a 5-minute warm up and then begin running at a rate and treadmill elevation that ensures that they are working at 76-96% of their age-adjusted maximum heart rate. An attendant will monitor their heart rate throughout the protocol to ensure compliance. The participant will continue to exercise while blood is drawn at 50-minutes of activity.
A butterfly needle will be inserted into the arm of their choice. A baseline sample of 5 ml of blood will be drawn immediately with subsequent 5 ml samples drawn at 25- and 50-minutes into the exercise protocol. A final 5 ml sample will be drawn at 30 minutes after completion of the protocol. The butterfly needle will be removed immediately after the final blood draw.
The endorphin response has been documented at 70% of age-adjusted maximum heart rate and increases linearly after that. A heart monitor will be worn throughout the trial to monitor exercise intensity which will be determined based on the ACSM guidelines for vigorous exercise, 76-96% of the participant's age-adjusted maximum heart rate (AAMHR). Participants will be instructed to perform a 5-minute warm up and then begin running. A monitor will ensure that the participant maintains the target intensity throughout the activity.
After completing the physical activity, participants will be offered healthy snacks while they walk, sit, or lie down anywhere within the lab. They will complete the second set of VAS ratings of emotional state that will be used to differentiate runners who experience "runner's high" from those who do not. The final 5 ml of blood will be drawn 30 minutes after completion of the exercise protocol after which the participant will take off the heart monitor and leave the lab.
After collection of the blood samples, the results will be separated into blood plasma. The blood plasma will be analyzed for extracellular vesicles and quantitative biochemical changes within said extracellular vesicles.
- Conditions
- Hormone Disturbance, Endorphin Changes
- Being tested
- Vigorous Exercise
- Medical subject headings
- Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigorous ExerciseBehavioural
50 minutes of running on a treadmill
| Study group | Role | What they receive |
|---|---|---|
| Vigorous Exercise | Experimental | 50 Minutes of running on a treadmill Receives: Behavioral: Vigorous Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Changes in Blood Plasma
Endorphin expression (AU arbitrary unit) in Extracellular Vesicles within Blood Plasma via Western Blot
Measured: 0 minutes into exercising
Biochemical Changes in Blood Plasma
Endorphin expression (AU arbitrary unit) in Extracellular Vesicles within Blood Plasma via Western Blot
Measured: 50 minutes into exercising
Biochemical Changes in Blood Plasma
Endorphin expression (AU arbitrary unit) in Extracellular Vesicles within Blood Plasma via Western Blot
Measured: 30 minutes after completion of exercising
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Mar 2023
- Primary completion1 May 2023
- Study completion23 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone DisturbanceStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 20 Male and Female Athletes Aged 18-65
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Touro University Nevada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Tai, Touro University Nevada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790772
- Sponsor's protocol ID
- TUNIRB000225
- Status last verified
- Jul 2023
- First submitted
- 6 Mar 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be made anonymous to protect their identity as data analysis begins.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Changes in Blood Plasma After Intense Physical Exercise of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05790772
- Acronym / sponsor ID
- TUNIRB000225
- Conditions
- Hormone Disturbance, Endorphin Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Touro University NevadaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 23 Jul 2023 (actual)
- First posted
- 30 Mar 2023 (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 study will recruit 20 male and female athletes of endurance training background. They will participate in 50 minutes of vigorous activity on a treadmill with 3 blood draws (before exercising, 50 minutes into exercising, and 30 minutes after completion of exercising). After collection of the blood samples, the results will be analyzed for extracellular vesicles and biochemical changes within said extracellular vesicles.
Detailed description
This study will recruit participants from the Touro University Nevada student body by placing flyers around campus and including announcements on the TUN screens. Program faculty will be encouraged to promote the study to their students through March.
20 male and female athletes who currently participate in regular endurance training will be recruited for the study. We will use men because the hormonal responses to exercise vary between men and women and is blunted at different points during the reproductive cycle. Participants recruited into the study will be normal weight (BMI or waist-to-hip ratio), and a history of regular participation in endurance training (see flyer). Participants will not have been diagnosed or treated for any psychiatric conditions, lower extremity or low back injury and will not have regularly taken any prescription medications within the past year.
Participants will be consented into the study, scheduled, and given pre-participation instructions one week prior to the event. They will not take over-the-counter medications or supplements within one week of the trial, have no alcohol within 72 hours and no caffeine or nicotine within four hours, and no food within two hours of the protocol. Participants may drink water ad libitum prior to the trial.
Upon arriving the day of the trial, participants will be screened by urinalysis for drug use. They will complete a survey based on the International Physical Activity Questionnaire which will be used to classify their history of physical activity. They will complete a pre-activity screen of their current emotional state using a set of Visual Analog Scales (VAS).
On the day of the trial, participants will provide a urine sample for urinalysis. They will complete an electronic survey on their cell phone and will complete a paper survey including a set of visual analog scales. A butterfly needle will be inserted into their arm of choice which will allow the four small (5 ml) blood samples to be drawn throughout the activity. The first sample will be drawn immediately upon inserting the needle with subsequent draws performed at 50-minutes of physical activity, and the final draw 30-minutes after the activity ends. They will wear a heart monitor that will be used to monitor exercise intensity throughout the exercise protocol.
Participants will complete an exercise protocol that includes 50 minutes of vigorous activity on a treadmill. They will be instructed to perform a 5-minute warm up and then begin running at a rate and treadmill elevation that ensures that they are working at 76-96% of their age-adjusted maximum heart rate. An attendant will monitor their heart rate throughout the protocol to ensure compliance. The participant will continue to exercise while blood is drawn at 50-minutes of activity.
A butterfly needle will be inserted into the arm of their choice. A baseline sample of 5 ml of blood will be drawn immediately with subsequent 5 ml samples drawn at 25- and 50-minutes into the exercise protocol. A final 5 ml sample will be drawn at 30 minutes after completion of the protocol. The butterfly needle will be removed immediately after the final blood draw.
The endorphin response has been documented at 70% of age-adjusted maximum heart rate and increases linearly after that. A heart monitor will be worn throughout the trial to monitor exercise intensity which will be determined based on the ACSM guidelines for vigorous exercise, 76-96% of the participant's age-adjusted maximum heart rate (AAMHR). Participants will be instructed to perform a 5-minute warm up and then begin running. A monitor will ensure that the participant maintains the target intensity throughout the activity.
After completing the physical activity, participants will be offered healthy snacks while they walk, sit, or lie down anywhere within the lab. They will complete the second set of VAS ratings of emotional state that will be used to differentiate runners who experience "runner's high" from those who do not. The final 5 ml of blood will be drawn 30 minutes after completion of the exercise protocol after which the participant will take off the heart monitor and leave the lab.
After collection of the blood samples, the results will be separated into blood plasma. The blood plasma will be analyzed for extracellular vesicles and quantitative biochemical changes within said extracellular vesicles.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 Male and Female Athletes Aged 18-65
| Arm | Type | Receives |
|---|---|---|
| Vigorous Exercise | Experimental | Behavioral: Vigorous Exercise50 Minutes of running on a treadmill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Has reportedly experienced "runner's high" during vigorous exercise.
Key exclusion criteria (1 listed)
- Has not reportedly experienced "runner's high" during vigorous exercise.
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 |
|---|---|---|
| Vigorous Exercise50 minutes of running on a treadmill | Behavioural | Vigorous Exercise |
Primary outcome
Biochemical Changes in Blood Plasma
Time frame: 0 minutes into exercising
Endorphin expression (AU arbitrary unit) in Extracellular Vesicles within Blood Plasma via Western Blot
Biochemical Changes in Blood Plasma
Time frame: 50 minutes into exercising
Endorphin expression (AU arbitrary unit) in Extracellular Vesicles within Blood Plasma via Western Blot
Biochemical Changes in Blood Plasma
Time frame: 30 minutes after completion of exercising
Endorphin expression (AU arbitrary unit) in Extracellular Vesicles within Blood Plasma via Western Blot
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 25 Jul 2023.
- Individual participant dataSharing planned: No. Individual participant data will be made anonymous to protect their identity as data analysis begins.
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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 Vigorous Exercise in people with Hormone Disturbance and Endorphin Changes, run by Touro University Nevada 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 1 inclusion and 1 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 25 Jul 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. 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?
Biochemical Changes in Blood Plasma (time frame: 0 minutes into exercising). The study lists 3 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 25 Jul 2023.