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Completed

NCT Number: NCT05000437

The Effectiveness and Safety of HIIT in Overweight Male Subjects

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fakultas Kedokteran Universitas Indonesia, Jakarta Pusat, DKI Jakarta, Indonesia

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About this study

  • Subjects are recruited via e-flyer distributed online across university departments. Individual who is interested in study participation fills out screening form. Research assistants screen subjects eligibility. Subjects are coded based on the order of screening form fulfillment.
  • Research assistants are using the standard operational procedures for each assessments. Training for the research assistants precedes the data collection to ensure the similarity of understanding and skills during measurements. One research assistant responsible for scheduling the assessments and training sessions. Continuous evaluation are planned weekly to provide room for improvements in the process of data collection.
  • Sample size assessment is measured from 5 primary output by a research assistants using sample size calculation website for single intervention clinical trial.
  • Investigator use paper based data collection for each assessment and during training sessions. Subject are encouraged to report any symptoms and signs during intervention period in each meeting with the research assistants or via online messaging. Any reports will be documented in separated form. One research assistant makes sure the data fields are completed in each measurements and during training sessions. The assistant also check the similarity of the data entered in the master table.
  • Data analysis will be lead by one research assistant using newest version of SPSS software. The analysis will be started after the baseline measurement is completed although the data collection is not finished. All numeric data will be presented as mean and standard deviations if normally distributed or median and minimum maximum range if not normally distributed. Paired t-test will be used to identify the difference before and after the intervention if the data are normally distributed. If the data are not normally distributed, Wilcoxon test will be used to identify the difference before and after the intervention.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • overweight (BMI 25 - 29,9)
  • live in Jakarta and greater area
  • willing to participate

Exclusion criteria

  • smoking
  • any medical health problems (epilepsy, cardiovascular disease, kidney and liver problems, history of fractures, tendon and ligament injuries)

Treatment and study plan

HIIT

Other

3x/week high intensity interval training for 12 weeks

Primary outcomes

  1. cardiorespiratory fitness

    Time frame: 12 weeks

    VO2Max in ml/kg/minute

  2. body mass index

    Time frame: week 4

    weight and height combined as BMI in kg/m2

  3. body mass index

    Time frame: week 8

    weight and height combined as BMI in kg/m2

  4. body mass index

    Time frame: week 12

    weight and height combined as BMI in kg/m2

  5. body fat mass

    Time frame: week 4

    total fat mass in the body as percentage

  6. body fat mass

    Time frame: week 8

    total fat mass in the body as percentage

  7. body fat mass

    Time frame: week 12

    total fat mass in the body as percentage

  8. visceral fat

    Time frame: week 4

    body fat stored within abdominal cavity as ratings

  9. visceral fat

    Time frame: week 8

    body fat stored within abdominal cavity as ratings

  10. visceral fat

    Time frame: week 12

    body fat stored within abdominal cavity as ratings

  11. waist circumference

    Time frame: week 4

    circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm

  12. waist circumference

    Time frame: week 8

    circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm

  13. waist circumference

    Time frame: week 12

    circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm

  14. lipid profile

    Time frame: 12 weeks

    total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride

  15. antioxidant level

    Time frame: 12 weeks

    SOD in U/mg

  16. free radicals level

    Time frame: 12 weeks

    MDA in nmol/mg

  17. inflammation

    Time frame: 12 weeks

    TNF-alpha in microgram/ml

  18. interleukin level

    Time frame: 12 weeks

    IL-6 nanogram/ml

Secondary outcomes

  1. Fat Burning Effect

    Time frame: week 1, 6, 12

    FGF21

  2. Myokin

    Time frame: week 1, 6, 12

    Irisin

  3. Cognitive Function Screening

    Time frame: week 1 and 12

    Montreal Cognitive Assessment as score

  4. Working memory Capacity

    Time frame: week 1 and 12

    N-Back test as percentage of correct answers

  5. Executive Function

    Time frame: week 1 and 12

    Trail Making Test A and B as seconds

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

The Effectiveness and Safety of High Intensity Interval Training Based on Oxidative Stress and Inflammatory Markers in the Management of Overweight Male Subjects

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 11, 2021
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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