NCT05790772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

March 6, 2023

Last Update Submit

July 24, 2023

Conditions

Hormone DisturbanceEndorphin Changes

Outcome Measures

Primary Outcomes (3)

  • Biochemical Changes in Blood Plasma

    Endorphin expression (AU arbitrary unit) in Extracellular Vesicles within Blood Plasma via Western Blot

    0 minutes into exercising

  • Biochemical Changes in Blood Plasma

    Endorphin expression (AU arbitrary unit) in Extracellular Vesicles within Blood Plasma via Western Blot

    50 minutes into exercising

  • Biochemical Changes in Blood Plasma

    Endorphin expression (AU arbitrary unit) in Extracellular Vesicles within Blood Plasma via Western Blot

    30 minutes after completion of exercising

Study Arms (1)

Vigorous Exercise

EXPERIMENTAL

50 Minutes of running on a treadmill

Behavioral: Vigorous Exercise

Interventions

Vigorous ExerciseBEHAVIORAL

50 minutes of running on a treadmill

Vigorous Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Touro University Nevada

Henderson, Nevada, 89014, United States

Location

MeSH Terms

Conditions

Endocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 20 Male and Female Athletes Aged 18-65
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 30, 2023

Study Start

March 1, 2023

Primary Completion

May 1, 2023

Study Completion

July 23, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will be made anonymous to protect their identity as data analysis begins.

Locations

US(1)