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Clinical Trials/NCT05790772
NCT05790772CompletedNot Applicable

Biochemical Changes in Blood Plasma After Intense Physical Exercise of Healthy Volunteers

Touro University Nevada2 sites in 1 country20 target enrollmentStarted: March 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Biochemical Changes in Blood Plasma

Study Overview

Brief 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). 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Has reportedly experienced "runner's high" during vigorous exercise.

Exclusion Criteria

  • Has not reportedly experienced "runner's high" during vigorous exercise.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Derek Tai

Principal Investigator

Touro University Nevada

Study Sites (2)

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