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

Obesity and Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409172
• Other study ID #: Aerobic exercise and obesity
• Status: Completed
• Phase: N/A
• First received: January 9, 2018
• Last updated: January 23, 2018
• Start date: June 1, 2016
• Est. completion date: January 8, 2018

Study information

• Verified date: January 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 8, 2018
• Est. primary completion date: January 8, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 41 Years

Eligibility

Inclusion Criteria:

• Body Mass Index between (30-40 kg/m²)

• age between 25 and 41 years

• to be sedentary

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)

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Obesity and Metabolic Syndrome

Intervention

Other:
• CTR
no counseling or nutritional therapy and no exercise
• MICT
no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based moderate continuous intensity training (MICT).
• HIIT
no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based high intensity interval training (HIIT)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory profile	C-reactive protein (CRP) (mg/dL)	8 weeks (baseline to 8 week follow-up assessment)
Primary	Inflammatory profile	Interleukin 6 (IL-6) (ng/mL)	8 weeks (baseline to 8 week follow-up assessment)
Primary	Inflammatory profile	Interleukin 10 (IL-10) pg/mL, Interleukin-1B (IL-1B) pg/mL, Tumor Necrosis Factor (TNF)-a (pg/mL), Adiponectin (pg/mL), Monocyte chemoattractant protein 1 (MCP-1) (pg/mL), Leptin (pg/mL)	8 weeks (baseline to 8 week follow-up assessment)
Secondary	Body Composition and Anthropometric profile	Body weight (kg), Fat free mass (FFM) (kg), fat mass (FM) (kg)	8 weeks (baseline to 8 week follow-up assessment) ]
Secondary	Body Composition and Anthropometric profile	Body Mass Index (BMI) (kg/m²)	8 weeks (baseline to 8 week follow-up assessment) ]
Secondary	Body Composition and Anthropometric profile	Waist circumference (cm), hip circumference (cm)	8 weeks (baseline to 8 week follow-up assessment) ]
Secondary	Body Composition and Anthropometric profile	Body Adiposity Index (BAI) and Waist-To-Hip Ratio (WHR)	8 weeks (baseline to 8 week follow-up assessment) ]
Secondary	Insulin sensitivity	Insulin sensitivity was estimated using homeostasis model assessment index (HOMA)	8 weeks (baseline to 8 week follow-up assessment) ]
Secondary	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)	8 weeks (baseline to 8 week follow-up assessment) ]
Secondary	Cardiorespiratory Fitness (CRF)	CRF was assessed by measuring Peak Oxygen uptake (VO2peak) mL/kg/min	8 weeks (baseline to 8 week follow-up assessment) ]
Secondary	Blood Pressure (BP)	Blood Pressure (mmHg) was assessed by measuring rest levels of Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)	8 weeks (baseline to 8 week follow-up assessment) ]
Secondary	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)	8 weeks (baseline to 8 week follow-up assessment) ]
Secondary	Substrate oxidation rate	Substrate oxidation rate was calculated from VO2 (mL/min) and VCO2 (mL/min)	8 weeks (baseline to 8 week follow-up assessment) ]