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Increased prevalence of overweight and obesity is one of the main health problems recently. Energy balance from nutrition intake and energy expenditure through physical activity, especially structured physical activity, is needed to prevent overweight individuals become obese individuals. This research objective is to explore the effectiveness and safety of structured high intensity interval training in male young adults subjects with overweight based on change of body composition, oxidative stress and inflammatory markers. This research used experimental model to test structured high intensity interval training program with pre-post test in single group. Comprehensive analysis of training effect in this research consists of measurement of several parameters, such as body composition, inflammatory markers, and oxidative stress markers as the benchmark of training safety. Browning white adipose tissue and cognitive function are complement parameters to the assessment of training effectiveness. Daily food record and physical activity for 3 x 24 hours will be carried out periodically to control confounding factors.
To ensure that there is no missing data, the research assistant who responsible for data completeness will perform daily checking. Any missing data will be stated and immediately completed. Research assistants will provide close supervision for each subject to ensure the delivery of all necessary reports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity Interval Training | Experimental | single arm intervention, with high intensity interval training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIIT | Other | 3x/week high intensity interval training for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| cardiorespiratory fitness | VO2Max in ml/kg/minute | 12 weeks |
| body mass index | weight and height combined as BMI in kg/m2 | week 4 |
| body mass index | weight and height combined as BMI in kg/m2 | week 8 |
| body mass index | weight and height combined as BMI in kg/m2 | week 12 |
| body fat mass | total fat mass in the body as percentage | week 4 |
| body fat mass | total fat mass in the body as percentage | week 8 |
| body fat mass | total fat mass in the body as percentage | week 12 |
| visceral fat | body fat stored within abdominal cavity as ratings | week 4 |
| visceral fat | body fat stored within abdominal cavity as ratings | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Fat Burning Effect | FGF21 | week 1, 6, 12 |
| Myokin | Irisin | week 1, 6, 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nani Sudarsono | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultas Kedokteran Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia | ||
| Universitas Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 8, 2021 | Mar 29, 2022 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| visceral fat | body fat stored within abdominal cavity as ratings | week 12 |
| waist circumference | circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm | week 4 |
| waist circumference | circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm | week 8 |
| waist circumference | circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm | week 12 |
| lipid profile | total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride | 12 weeks |
| antioxidant level | SOD in U/mg | 12 weeks |
| free radicals level | MDA in nmol/mg | 12 weeks |
| inflammation | TNF-alpha in microgram/ml | 12 weeks |
| interleukin level | IL-6 nanogram/ml | 12 weeks |
| Cognitive Function Screening |
Montreal Cognitive Assessment as score |
| week 1 and 12 |
| Working memory Capacity | N-Back test as percentage of correct answers | week 1 and 12 |
| Executive Function | Trail Making Test A and B as seconds | week 1 and 12 |
| Jakarta Pusat |
| DKI Jakarta |
| 10430 |
| Indonesia |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |