Clinical trial NCT05000437: The Effectiveness and Safety of HIIT in Overweight Male Subjects
Official title: The Effectiveness and Safety of High Intensity Interval Training Based on Oxidative Stress and Inflammatory Markers in the Management of Overweight Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Overweight or Obesity
Keywords: high intensity interval training
overweight
young male
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: * 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.

Eligibility criteria: 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)

Primary outcomes:
measure: cardiorespiratory fitness
timeFrame: 12 weeks
measure: body mass index
timeFrame: week 4
measure: body mass index
timeFrame: week 8
measure: body mass index
timeFrame: week 12
measure: body fat mass
timeFrame: week 4
measure: body fat mass
timeFrame: week 8
measure: body fat mass
timeFrame: week 12
measure: visceral fat
timeFrame: week 4
measure: visceral fat
timeFrame: week 8
measure: visceral fat
timeFrame: week 12
measure: waist circumference
timeFrame: week 4
measure: waist circumference
timeFrame: week 8
measure: waist circumference
timeFrame: week 12
measure: lipid profile
timeFrame: 12 weeks
measure: antioxidant level
timeFrame: 12 weeks
measure: free radicals level
timeFrame: 12 weeks
measure: inflammation
timeFrame: 12 weeks
measure: interleukin level
timeFrame: 12 weeks
Secondary outcomes:
measure: Fat Burning Effect
timeFrame: week 1, 6, 12
measure: Myokin
timeFrame: week 1, 6, 12
measure: Cognitive Function Screening
timeFrame: week 1 and 12
measure: Working memory Capacity
timeFrame: week 1 and 12
measure: Executive Function
timeFrame: week 1 and 12
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Fakultas Kedokteran Universitas Indonesia
state: DKI Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Nani Sudarsono
role: PRINCIPAL_INVESTIGATOR
References: