- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06217068
Comparative Analysis of Biomarkers in Response to Acute Moderate-Intensity Activity
Comparative Analysis of Biomarkers in Physically Active and Sedentary College Students
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Jennifer L Gay, PhD
- Phone Number: 706-542-6698
- Email: jlgay@uga.edu
Study Contact Backup
- Name: Jamie Cooper, PhD
- Email: jamie.cooper@uga.edu
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
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Jennifer L Gay, PhD, University of Georgia
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Biomarkers
-
Peking UniversityCompleted
-
University of MinnesotaCompleted
-
University of California, DavisUSDA, Western Human Nutrition Research CenterRecruiting
-
Harvard School of Public Health (HSPH)CompletedBiomarkersUnited States
-
West China HospitalRecruitingBiomarkers | NeonateChina
-
U.S. Army Medical Research and Development CommandWalter Reed Army Institute of Research (WRAIR)CompletedBiomarkers, PharmacologicalUnited States
-
Five Liters, Inc.Northwell Health; The Feinstein Institutes for Medical ResearchRecruitingHemostasis | Blood BiomarkersUnited States
-
CareDxRecruitingLiver Transplantation | BiomarkersUnited States
-
Washington State UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedInteraction | Endogenous BiomarkersUnited States
-
Claudine MANACHNational Research Agency, FranceCompletedBiomarkers | Food IntakeFrance
Clinical Trials on Elliptical Activity
-
National Institutes of Health Clinical Center (CC)United States Department of Defense; Henry M. Jackson Foundation for the Advancement... and other collaboratorsCompletedTraumatic Brain Injury | Adult | fMRIUnited States
-
Universitat Jaume IFundación Trinidad Alfonso; Fundación Hospitales NISA; SD. CorrecaminosCompleted
-
Cairo UniversityUnknownDiabetes Mellitus, Type 2Egypt
-
Ahram Canadian UniversityRecruitingPeripheral Arterial DiseaseEgypt
-
Instituto Mexicano del Seguro SocialUnknown
-
University of WashingtonCompletedQuality of Life | Multiple Sclerosis | Fatigue | Activity, MotorUnited States
-
Shirley Ryan AbilityLabNorthwestern University; Fitness Cubed Inc.RecruitingArthritis | Joint Diseases | Musculoskeletal Diseases | Rheumatic Diseases | Osteoarthritis | Knee OsteoarthritisUnited States
-
Universidade Federal de Sao CarlosCompletedHealthy | Chronic Obstructive Pulmonary DiseaseBrazil
-
Queen Mary University of LondonUnknownEosinophilic Esophagitis | Churg-Strauss Syndrome | Eosinophilic Asthma | Eosinophilic PneumoniaUnited Kingdom
-
Cairo UniversityUnknownMetabolic SyndromeEgypt