Biochemical Changes in Blood Plasma After Intense Physical Exercise of Healthy Volunteers
NCT ID: NCT05790772
Last Updated: 2023-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2023-03-01
2023-07-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exercise Induced Changes in Fat Metabolism
NCT02581306
Assessments of Adipogenesis, Lipid Turnover and Cellular Composition in Adipose Tissue in Response to Endurance Exercise
NCT06602141
Time-restricted Eating and High Intensity Interval Training Among Women
NCT04019860
Physical Activity and Basal Metabolic Rate in Postmenopausal Women
NCT01550536
Comparing the Effects of Exercise on the Structure and Function of Fat Tissue
NCT05328570
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vigorous Exercise
50 Minutes of running on a treadmill
Vigorous Exercise
50 minutes of running on a treadmill
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vigorous Exercise
50 minutes of running on a treadmill
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Touro University Nevada
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Derek Tai
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Touro University Nevada
Henderson, Nevada, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TUNIRB000225
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.