- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03700827
Effects of Aerobic and Resistance Training on Abdominal Fat Loss
September 27, 2021 updated by: Southern Illinois University Edwardsville
Study the effects of different exercise modes on total and regional adiposity variation in subcutaneous and visceral adipose tissue (VAT and SAT).
The investigators hypothesize that total abdominal will improve for all the exercise groups compared to the control group.
When comparing intervention groups: 1) no differences on the degree of improvement in total abdominal fat depots (VAT and SAT) 2) different degree of change when comparing specific sections at VAT and SAT are expected.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Edwardsville, Illinois, United States, 62026
- Southern Illinois University of Edwardsville
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-
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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 30 - 39.9 kg/m2 BMI
- White/Caucasian
- Female
- Sedentary
Exclusion Criteria:
- Known cardiovascular, pulmonary, metabolic disease
- Pregnant females
- Any excluded criteria with MRI scans (i.e. certain metal implants, recent tattoos)
- Diabetic
- Hypertension
- Cigarette smoking
- MRI related contraindications (metal, no removable devices, etc.)
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance Training Group
Resistance training will consist of 3 whole body circuits per week for 3 weeks lasting approximately 1 hour per session.
All major muscle groups will be involved (leg press, bent-over-row, bench press, back squat, dumbbell jump squats, dead-lifts, and weighted abdominal crunches).
Each participant will go through each circuit three times with 30 seconds between each exercise and 2 minutes between each set.
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High-intensity Resistance Training Group
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|
Experimental: Aerobic Training Group
Aerobic interval training will consist of 3 sessions/week for 3 weeks for approximately 45-50 minutes per session depending on exercise energy expenditure.
There will be two periods of intervals.
The first period will be 3 minutes of high-intensity activity and the second period will be reduced to moderate-intensity for 2 minutes.
The speed/incline will change depending on the participants perception or Borg's rating of perceived exertion.
Intensity will be measured using Lactate levels after each session.
|
Aerobic Interval Training Group
|
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No Intervention: Control Group
The control group must attend sessions but will not exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Visceral Abdominal Tissue (VAT)
Time Frame: 2 assessment periods: at baseline and week 4
|
Changes in VAT will be measured using Magnetic Resonance Imaging
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2 assessment periods: at baseline and week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Subcutaneous Abdominal Tissue (SAT)
Time Frame: 2 assessment periods: at baseline and week 4
|
Changes in SAT will be measured using Magnetic Resonance Imaging
|
2 assessment periods: at baseline and week 4
|
|
Changes in Muscular Strength
Time Frame: 2 assessment periods: at baseline and week 4
|
Changes in muscular strength will be assessed by one-repetition maximum test on leg press and bench press
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2 assessment periods: at baseline and week 4
|
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Changes in Cardiorespiratory Function
Time Frame: 2 assessment periods: at baseline and week 4
|
Changes in cardiorespiratory will measured on a treadmill with a metabolic cart
|
2 assessment periods: at baseline and week 4
|
|
Changes in fat mass (kg)
Time Frame: 2 assessment periods: at baseline and week 4
|
Changes in fat mass will be measured using dual-energy x-ray absorptiometry
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2 assessment periods: at baseline and week 4
|
|
Changes in relative body fat (%BF)
Time Frame: 2 assessment periods: at baseline and week 4
|
Changes in body composition (relative body fat, lean body mass and fat mass) will be measured using dual-energy x-ray absorptiometry
|
2 assessment periods: at baseline and week 4
|
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Changes in relative lean body mass (kg)
Time Frame: 2 assessment periods: at baseline and week 4
|
Changes in lean body mass will be measured using dual-energy x-ray absorptiometry
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2 assessment periods: at baseline and week 4
|
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Changes in Lipid profile (TG, Total Cholesterol, HDL2 HDL3, LDL)
Time Frame: 2 assessment periods: at baseline and week 4
|
Samples will be processed to obtain serum and plasma, and stored at -80°c until analysis
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2 assessment periods: at baseline and week 4
|
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Changes in concentration of Troponin
Time Frame: 2 assessment periods: at baseline and week 4
|
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
|
2 assessment periods: at baseline and week 4
|
|
Changes in concentration of Fibrinogen
Time Frame: 2 assessment periods: at baseline and week 4
|
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
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2 assessment periods: at baseline and week 4
|
|
Changes in concentration of C-reactive protein (CRP)
Time Frame: 2 assessment periods: at baseline and week 4
|
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
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2 assessment periods: at baseline and week 4
|
|
Changes in concentration of IL-6
Time Frame: 2 assessment periods: at baseline and week 4
|
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
|
2 assessment periods: at baseline and week 4
|
|
Changes in concentration of IL-10
Time Frame: 2 assessment periods: at baseline and week 4
|
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
|
2 assessment periods: at baseline and week 4
|
|
Changes in concentration of TNF-alpha
Time Frame: 2 assessment periods: at baseline and week 4
|
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
|
2 assessment periods: at baseline and week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Maria Fernandez del Valle, PhD, Southern Illinois University of Edwardsville
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 (Actual)
October 1, 2017
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
September 5, 2018
First Submitted That Met QC Criteria
October 5, 2018
First Posted (Actual)
October 9, 2018
Study Record Updates
Last Update Posted (Actual)
October 4, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-1208-4C-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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