NCT06217068

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2024

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

First Submitted

Initial submission to the registry

January 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

January 10, 2024

Last Update Submit

February 18, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Ammonia

    Blood sample

    Pre-test and post-test (immediately following exercise)

  • Insulin

    Blood sample

    Pre-test and post-test (immediately following exercise)

  • Cortisol

    Blood sample

    Pre-test and post-test (immediately following exercise)

  • C-reactive protein

    Blood sample

    Pre-test and post-test (immediately following exercise)

  • Glucose

    Blood sample

    Pre-test and post-test (immediately following exercise)

Study Arms (2)

Sedentary Individuals - Acute Moderate-Intensity Exercise

EXPERIMENTAL

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.

Behavioral: Elliptical Activity

Active Individuals - Acute Moderate-Intensity Exercise

EXPERIMENTAL

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.

Behavioral: Elliptical Activity

Interventions

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.

Active Individuals - Acute Moderate-Intensity ExerciseSedentary Individuals - Acute Moderate-Intensity Exercise

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

Study Officials

  • Jennifer L Gay, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Lab processing the blood samples is blinded to participant group.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two group pre-test post-test study where groups are determined by current activity level (sedentary versus active). The dose of exercise is being tested between groups to see if there are differential effects of this acute dose at this intensity on biomarkers.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 22, 2024

Study Start

March 11, 2024

Primary Completion

February 7, 2025

Study Completion

February 7, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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

Locations