Obesity, AbdominalNCT03700827
Effects of Aerobic and Resistance Training on Abdominal Fat Loss
A study testing Resistance Training and Aerobic Training in people with Obesity, Abdominal, run by Southern Illinois University Edwardsville at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- Resistance Training and Aerobic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 30 - 39.9 kg/m2 BMI
- White/Caucasian
- Female
- Sedentary
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University of Edwardsville
Edwardsville, Illinois, 62026
About this study
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.
- Conditions
- Obesity, Abdominal
- Being tested
- Resistance Training, Aerobic Training
- Keywords
- Abdominal Fat, Visceral Adipose Tissue, Subcutaneous Adipose Tissue, Exercise, Intervention
- Medical subject headings
- Obesity, Abdominal, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
High-intensity Resistance Training Group
Aerobic TrainingOther
Aerobic Interval Training Group
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training Group | Experimental | 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. Receives: Other: Resistance Training |
| Aerobic Training Group | Experimental | 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. Receives: Other: Aerobic Training |
| Control Group | No intervention | The control group must attend sessions but will not exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Visceral Abdominal Tissue (VAT)
Changes in VAT will be measured using Magnetic Resonance Imaging
Measured: 2 assessment periods: at baseline and week 4
Secondary outcomes (13)
Changes in Subcutaneous Abdominal Tissue (SAT)
Changes in SAT will be measured using Magnetic Resonance Imaging
Measured: 2 assessment periods: at baseline and week 4
Changes in Muscular Strength
Changes in muscular strength will be assessed by one-repetition maximum test on leg press and bench press
Measured: 2 assessment periods: at baseline and week 4
Changes in Cardiorespiratory Function
Changes in cardiorespiratory will measured on a treadmill with a metabolic cart
Measured: 2 assessment periods: at baseline and week 4
Changes in fat mass (kg)
Changes in fat mass will be measured using dual-energy x-ray absorptiometry
Measured: 2 assessment periods: at baseline and week 4
Changes in relative body fat (%BF)
Changes in body composition (relative body fat, lean body mass and fat mass) will be measured using dual-energy x-ray absorptiometry
Measured: 2 assessment periods: at baseline and week 4
Changes in relative lean body mass (kg)
Changes in lean body mass will be measured using dual-energy x-ray absorptiometry
Measured: 2 assessment periods: at baseline and week 4
Changes in Lipid profile (TG, Total Cholesterol, HDL2 HDL3, LDL)
Samples will be processed to obtain serum and plasma, and stored at -80°c until analysis
Measured: 2 assessment periods: at baseline and week 4
Changes in concentration of Troponin
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
Measured: 2 assessment periods: at baseline and week 4
Changes in concentration of Fibrinogen
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
Measured: 2 assessment periods: at baseline and week 4
Changes in concentration of C-reactive protein (CRP)
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
Measured: 2 assessment periods: at baseline and week 4
Changes in concentration of IL-6
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
Measured: 2 assessment periods: at baseline and week 4
Changes in concentration of IL-10
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
Measured: 2 assessment periods: at baseline and week 4
Changes in concentration of TNF-alpha
Will be performed using a Luminex MAGPIX System with xPONENT 4.2
Measured: 2 assessment periods: at baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Oct 2017
- Primary completion1 Apr 2020
- Study completion1 May 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University Edwardsville
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Maria Fernandez del Valle, PhD, Principal investigator, Southern Illinois University of Edwardsville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700827
- Sponsor's protocol ID
- 16-1208-4C-2
- Status last verified
- Mar 2021
- First submitted
- 5 Sep 2018
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic and Resistance Training on Abdominal Fat Loss
- ClinicalTrials.gov ID
- NCT03700827
- Acronym / sponsor ID
- 16-1208-4C-2
- Conditions
- Obesity, Abdominal
- Keywords
- Abdominal Fat, Visceral Adipose Tissue, Subcutaneous Adipose Tissue, Exercise, Intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Southern Illinois University EdwardsvilleUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance Training Group | Experimental | Other: Resistance TrainingResistance 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. |
| Aerobic Training Group | Experimental | Other: Aerobic TrainingAerobic 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. |
| Control Group | No intervention | –The control group must attend sessions but will not exercise. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 30 - 39.9 kg/m2 BMI
- White/Caucasian
- Female
- Sedentary
Key exclusion criteria (7 listed)
- Known cardiovascular, pulmonary, metabolic disease
- Pregnant females
- Any excluded criteria with MRI scans (i.e. certain metal implants, recent tattoos)
- Diabetic
- Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance TrainingHigh-intensity Resistance Training Group | Other | Resistance Training Group |
| Aerobic TrainingAerobic Interval Training Group | Other | Aerobic Training Group |
Primary outcome
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
13 secondary outcomes
Changes in Subcutaneous Abdominal Tissue (SAT)
Time frame: 2 assessment periods: at baseline and week 4
Changes in Muscular Strength
Time frame: 2 assessment periods: at baseline and week 4
Changes in Cardiorespiratory Function
Time frame: 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 relative body fat (%BF)
Time frame: 2 assessment periods: at baseline and week 4
Changes in relative lean body mass (kg)
Time frame: 2 assessment periods: at baseline and week 4
Changes in Lipid profile (TG, Total Cholesterol, HDL2 HDL3, LDL)
Time frame: 2 assessment periods: at baseline and week 4
Changes in concentration of Troponin
Time frame: 2 assessment periods: at baseline and week 4
Changes in concentration of Fibrinogen
Time frame: 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
Changes in concentration of IL-6
Time frame: 2 assessment periods: at baseline and week 4
Changes in concentration of IL-10
Time frame: 2 assessment periods: at baseline and week 4
Changes in concentration of TNF-alpha
Time frame: 2 assessment periods: at baseline and week 4
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Fernandez del Valle, PhD principal investigator
Southern Illinois University of Edwardsville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training and Aerobic Training in people with Obesity, Abdominal, run by Southern Illinois University Edwardsville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Visceral Abdominal Tissue (VAT) (time frame: 2 assessment periods: at baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.