Obesity and Metabolic SyndromeNCT03409172
Inflammatory and Metabolic Outcomes After Obese Woman Performed High Intensity Interval Training
A study testing CTR, MICT and HIIT in people with Obesity and Metabolic Syndrome, run by University of Sao Paulo.
Trial summary
The main purpose of this study is to compare the effects of high intensity interval training and moderate intensity continuous training on inflammatory profile and metabolic markers, after 8 weeks of intervention trial in obese women. Read more about this study
- Who is it for?
- Ages 25 to 41 years, women only
- Conditions the study is for
- Obesity and Metabolic Syndrome
- What is being tested?
- CTR, MICT and HIIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 8 Jan 2018
- 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 25 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Body Mass Index between (30-40 kg/m²)
- age between 25 and 41 years
- to be sedentary
Who cannot join
- type 1 or type 2 diabetes
- Hypertension
- pregnancy, Lactation
- having undergone bariatric surgery
- psychological disorders, epilepsy, sever neurological disorders
- participation in other moderate, vigorous exercise or nutrition intervention
Show all 14Show fewer
- acute or chronic cardiovascular disease
- malignant disease
- kidney disease
- lung disease
- hyperthyroidism or hypothyroidism
- smoking any type of cigarette
- joint limitations
- electronic implants (defibrillator, pacemaker)
About this study
Official title: Inflammatory and Metabolic Outcomes in Obese Women After 8 Weeks of High Intensity Interval Training and Moderate Intensity Continuous Training: a Randomized Controlled Pilot Study
The main purpose of this study is to compare the effects of high intensity interval training and moderate intensity continuous training on inflammatory profile and metabolic markers, after 8 weeks of intervention trial in obese women.
- Conditions
- Obesity and Metabolic Syndrome
- Being tested
- CTR, MICT, HIIT
- Keywords
- High intensity interval training, Inflammation, Obesity, adipokines
- Medical subject headings
- Obesity, Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTROther
no counseling or nutritional therapy and no exercise
MICTOther
no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based moderate continuous intensity training (MICT).
HIITOther
no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based high intensity interval training (HIIT)
| Study group | Role | What they receive |
|---|---|---|
| Control group (CTr) | Experimental | No counseling or nutritional therapy and no exercise Receives: Other: CTR |
| Moderate intensity continuous training (MICT) | Experimental | Follow-up during a period of 8 weeks of supervised ergometer-based moderate-intensity continuous training based on HRmax (MICT).
MICT:
* 3 sessions per week
* intensity at 65-75% HRmax
* time-effort per session: 50 min Receives: Other: MICT |
| High Intensity Interval Training (HIIT) | Experimental | Procedures: Follow-up during a period of 8 weeks of supervised ergometer-based high intensity interval training based on HRmax (HIIT).
HIIT:
* 3 sessions per week
* 10 bouts of one minute at 90% HRmax interspersed by one minute at 40% HRmax
* time-effort per session: 25 min Receives: Other: HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory profile
C-reactive protein (CRP) (mg/dL)
Measured: 8 weeks (baseline to 8 week follow-up assessment)
Inflammatory profile
Interleukin 6 (IL-6) (ng/mL)
Measured: 8 weeks (baseline to 8 week follow-up assessment)
Inflammatory profile
Interleukin 10 (IL-10) pg/mL, Interleukin-1B (IL-1B) pg/mL, Tumor Necrosis Factor (TNF)-α (pg/mL), Adiponectin (pg/mL), Monocyte chemoattractant protein 1 (MCP-1) (pg/mL), Leptin (pg/mL)
Measured: 8 weeks (baseline to 8 week follow-up assessment)
Secondary outcomes (10)
Body Composition and Anthropometric profile
Body weight (kg), Fat free mass (FFM) (kg), fat mass (FM) (kg)
Measured: 8 weeks (baseline to 8 week follow-up assessment) ]
Body Composition and Anthropometric profile
Body Mass Index (BMI) (kg/m²)
Measured: 8 weeks (baseline to 8 week follow-up assessment) ]
Body Composition and Anthropometric profile
Waist circumference (cm), hip circumference (cm)
Measured: 8 weeks (baseline to 8 week follow-up assessment) ]
Body Composition and Anthropometric profile
Body Adiposity Index (BAI) and Waist-To-Hip Ratio (WHR)
Measured: 8 weeks (baseline to 8 week follow-up assessment) ]
Insulin sensitivity
Insulin sensitivity was estimated using homeostasis model assessment index (HOMA)
Measured: 8 weeks (baseline to 8 week follow-up assessment) ]
Lipid profile
Lipid profile was assessed by measuring levels of triglyceride (TG) (mg/dL), total cholesterol (CT) (mg/dL), high-density lipoprotein cholesterol (HDL-C) (mg/dL) and low-density lipoprotein cholesterol (LDL-C) (mg/dL)
Measured: 8 weeks (baseline to 8 week follow-up assessment) ]
Cardiorespiratory Fitness (CRF)
CRF was assessed by measuring Peak Oxygen uptake (VO2peak) mL/kg/min
Measured: 8 weeks (baseline to 8 week follow-up assessment) ]
Blood Pressure (BP)
Blood Pressure (mmHg) was assessed by measuring rest levels of Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
Measured: 8 weeks (baseline to 8 week follow-up assessment) ]
Resting Energy Expenditure (REE)
Resting Energy Expenditure (kcal/day) was measured through indirect calorimetry with an open-circuit ventilated-hood system Substrate oxidation rate was calculated from VO2 (mL/min) and VCO2 (mL/min)
Measured: 8 weeks (baseline to 8 week follow-up assessment) ]
Substrate oxidation rate
Substrate oxidation rate was calculated from VO2 (mL/min) and VCO2 (mL/min)
Measured: 8 weeks (baseline to 8 week follow-up assessment) ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start1 Jun 2016
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Model description
- Three-arm parallel, Randomized-controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivian Marques Miguel Suen, University of Sao Paulo
- Investigators
- Vivian M M SUEN, PhD, Study director, fmrp usp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409172
- Sponsor's protocol ID
- Aerobic exercise and obesity
- Status last verified
- Jan 2018
- First submitted
- 9 Jan 2018
- Last updated
- 24 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory and Metabolic Outcomes in Obese Women After 8 Weeks of High Intensity Interval Training and Moderate Intensity Continuous Training: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03409172
- Acronym / sponsor ID
- Aerobic exercise and obesity
- Conditions
- Obesity and Metabolic Syndrome
- Keywords
- High intensity interval training, Inflammation, Obesity, adipokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 24 Jan 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.
The main purpose of this study is to compare the effects of high intensity interval training and moderate intensity continuous training on inflammatory profile and metabolic markers, after 8 weeks of intervention trial in obese women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel, Randomized-controlled study
| Arm | Type | Receives |
|---|---|---|
| Control group (CTr) | Experimental | Other: CTRNo counseling or nutritional therapy and no exercise |
| Moderate intensity continuous training (MICT) | Experimental | Other: MICTFollow-up during a period of 8 weeks of supervised ergometer-based moderate-intensity continuous training based on HRmax (MICT). MICT: * 3 sessions per week * intensity at 65-75% HRmax * time-effort per session: 50 min |
| High Intensity Interval Training (HIIT) | Experimental | Other: HIITProcedures: Follow-up during a period of 8 weeks of supervised ergometer-based high intensity interval training based on HRmax (HIIT). HIIT: * 3 sessions per week * 10 bouts of one minute at 90% HRmax interspersed by one minute at 40% HRmax * time-effort per session: 25 min |
Who may qualify
- Ages
- 25 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index between (30-40 kg/m²)
- age between 25 and 41 years
- to be sedentary
Key exclusion criteria (14 listed)
- type 1 or type 2 diabetes
- Hypertension
- pregnancy, Lactation
- having undergone bariatric surgery
- psychological disorders, epilepsy, sever neurological disorders
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 |
|---|---|---|
| CTRno counseling or nutritional therapy and no exercise | Other | Control group (CTr) |
| MICTno counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based moderate continuous intensity training (MICT). | Other | Moderate intensity continuous training (MICT) |
| HIITno counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based high intensity interval training (HIIT) | Other | High Intensity Interval Training (HIIT) |
Primary outcome
Inflammatory profile
Time frame: 8 weeks (baseline to 8 week follow-up assessment)
C-reactive protein (CRP) (mg/dL)
Inflammatory profile
Time frame: 8 weeks (baseline to 8 week follow-up assessment)
Interleukin 6 (IL-6) (ng/mL)
Inflammatory profile
Time frame: 8 weeks (baseline to 8 week follow-up assessment)
Interleukin 10 (IL-10) pg/mL, Interleukin-1B (IL-1B) pg/mL, Tumor Necrosis Factor (TNF)-α (pg/mL), Adiponectin (pg/mL), Monocyte chemoattractant protein 1 (MCP-1) (pg/mL), Leptin (pg/mL)
10 secondary outcomes
Body Composition and Anthropometric profile
Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Body Composition and Anthropometric profile
Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Body Composition and Anthropometric profile
Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Body Composition and Anthropometric profile
Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Insulin sensitivity
Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Lipid profile
Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Cardiorespiratory Fitness (CRF)
Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Blood Pressure (BP)
Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Resting Energy Expenditure (REE)
Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Substrate oxidation rate
Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Vivian M M SUEN, PhD study director
fmrp usp
Questions about this trial
What is this clinical trial studying?
A study testing CTR, MICT and HIIT in people with Obesity and Metabolic Syndrome, run by University of Sao Paulo.
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inflammatory profile (time frame: 8 weeks (baseline to 8 week follow-up assessment)). The study lists 3 primary outcomes in all. 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 24 Jan 2018.