Comparative Analysis of Biomarkers in Response to Acute Moderate-Intensity Activity

March 5, 2024 updated by: Jennifer Gay, University of Georgia

Comparative Analysis of Biomarkers in Physically Active and Sedentary College Students

The purpose of this study is to understand how college students' biomarkers change with a relatively short bout of moderate-intensity physical activity. The investigators are comparing biomarkers in between self-reported physically active and sedentary students in terms of their percent difference and change. The investigators are also studying physically active versus sedentary college students' mental health. This is a mentored student research project in the investigator's lab (not part of a thesis, dissertation, or other coursework requirements), where multiple students have developed research questions using the same study design.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

This study will use a two-group (sedentary versus active) pre-test, post-test study design. Following the informed consent process, participants will complete the pre-test data collection protocol including the first venipuncture blood draw for ammonia, insulin, cortisol, and c-reactive protein, first finger stick blood sample for glucose measurement, reporting of food eaten for the day as well as transportation methods to the study site. Resting heart rate will be measured.

Following a 15-minute waiting period to minimize potential effects from the blood draw, participants will walk with a study team member to a reserved elliptical machine. For the exercise component, the lab member will emphasize to the participant about maintaining the desired heart rate for moderate intensity exercise. The participant will use the elliptical for 12 minutes, without music, conversation, or general entertainment. Appropriate warm-up and cool-down is added in to the exercise time (the first two minutes and last two minutes) with preference of moderate intensity exercise lasting 8 minutes.

Participants will then walk with the study team member back to the Lab for post-test data collection. Post-test data collection follows the same procedures as pre-test data collection. Participants also will take a mental health questionnaire.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jennifer L Gay, PhD
  • Phone Number: 706-542-6698
  • Email: jlgay@uga.edu

Study Contact Backup

Study Locations

    • Georgia
      • Athens, Georgia, United States, 30602
        • Recruiting
        • University of Georgia
        • Contact:
          • Jennifer Gay, PhD
          • Phone Number: 706-542-6698
          • Email: jlgay@uga.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • This study will enroll full-time students at the investigator's university who are aged 18-34 years.
  • Participants will be generally healthy participants, assessed using the 2020 Physical Activity Readiness Questionnaire (first 7 questions) as a screening tool. Individuals who answer "no" to all of the 7 questions will be deemed healthy enough to take part.
  • Two balanced groups will be created based on self-reported current activity level, either sedentary (<30min/week of exercise) or meeting exercise guidelines (>=150min/week of exercise).
  • Potential participants should be willing to complete the blood draws and the 12 minutes of moderate-intensity exercise on an elliptical machine.
  • Potential participants should be able to speak and read the English language. This is so they will be able to understand the study protocols clearly.

Exclusion Criteria:

  • Are allergic to nuts because the snacks provided following the blood draw may contain nut products.
  • Do not have transportation and parking (if needed) to lab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sedentary Individuals - Acute Moderate-Intensity Exercise
8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity.
8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity.
Experimental: Active Individuals - Acute Moderate-Intensity Exercise
8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity.
8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ammonia
Time Frame: Pre-test and post-test (immediately following exercise)
Blood sample
Pre-test and post-test (immediately following exercise)
Insulin
Time Frame: Pre-test and post-test (immediately following exercise)
Blood sample
Pre-test and post-test (immediately following exercise)
Cortisol
Time Frame: Pre-test and post-test (immediately following exercise)
Blood sample
Pre-test and post-test (immediately following exercise)
C-reactive protein
Time Frame: Pre-test and post-test (immediately following exercise)
Blood sample
Pre-test and post-test (immediately following exercise)
Glucose
Time Frame: Pre-test and post-test (immediately following exercise)
Blood sample
Pre-test and post-test (immediately following exercise)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jennifer L Gay, PhD, University of Georgia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 11, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PROJECT00008178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not anticipate sharing individual, identified data to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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