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CompletedNCT03409172Updated Jan 24, 2018

Inflammatory and Metabolic Outcomes After Obese Woman Performed High Intensity Interval Training

An interventional study of CTR and MICT in Obesity and Metabolic Syndrome, sponsored by University of Sao Paulo. Completed. Open to female participants aged 25 Years to 41 Years. Per ClinicalTrials.gov, last updated 2018-01-24.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
25 Years to 41 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Obesity and Metabolic Syndrome

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Keywords

  • High intensity interval training
  • Inflammation
  • Obesity
  • adipokines
03

Who can participate

Ages eligible
25 Years to 41 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Body Mass Index between (30-40 kg/m²)
  • age between 25 and 41 years
  • to be sedentary

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Control group (CTr)

    No counseling or nutritional therapy and no exercise

    Other: CTR

  • Experimental
    Moderate intensity continuous training (MICT)

    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

    Other: MICT

  • Experimental
    High Intensity Interval Training (HIIT)

    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

    Other: HIIT

Interventions

  • OtherCTR

    no counseling or nutritional therapy and no exercise

  • OtherMICT

    no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based moderate continuous intensity training (MICT).

  • OtherHIIT

    no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based high intensity interval training (HIIT)

05

What researchers measure

Primary outcomes

  1. Inflammatory profile

    C-reactive protein (CRP) (mg/dL)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment)

  2. Inflammatory profile

    Interleukin 6 (IL-6) (ng/mL)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment)

  3. 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)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment)

Secondary outcomes

  1. Body Composition and Anthropometric profile

    Body weight (kg), Fat free mass (FFM) (kg), fat mass (FM) (kg)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

  2. Body Composition and Anthropometric profile

    Body Mass Index (BMI) (kg/m²)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

  3. Body Composition and Anthropometric profile

    Waist circumference (cm), hip circumference (cm)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

  4. Body Composition and Anthropometric profile

    Body Adiposity Index (BAI) and Waist-To-Hip Ratio (WHR)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

  5. Insulin sensitivity

    Insulin sensitivity was estimated using homeostasis model assessment index (HOMA)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

  6. 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)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

  7. Cardiorespiratory Fitness (CRF)

    CRF was assessed by measuring Peak Oxygen uptake (VO2peak) mL/kg/min

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

  8. Blood Pressure (BP)

    Blood Pressure (mmHg) was assessed by measuring rest levels of Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

  9. 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)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

  10. Substrate oxidation rate

    Substrate oxidation rate was calculated from VO2 (mL/min) and VCO2 (mL/min)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03409172
Lead sponsor
University of Sao Paulo
Responsible party
Vivian Marques Miguel Suen (Professor, University of Sao Paulo) — Principal investigator
First posted
Jan 24, 2018
Start date
Jun 1, 2016
Primary completion
Jan 8, 2018
Completion
Jan 8, 2018
Last update
Jan 24, 2018

Study contacts

Vivian M M SUEN, PhD
study director · fmrp usp

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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