The Effectiveness and Safety of HIIT in Overweight Male Subjects

Overweight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05000437
• Other study ID #: 20-09-1081
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 31, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Overweight
• Overweight or Obesity

Intervention

Other:
• HIIT
3x/week high intensity interval training for 12 weeks

Locations

Country	Name	City	State
Indonesia	Fakultas Kedokteran Universitas Indonesia	Jakarta Pusat	DKI Jakarta
Indonesia	Universitas Indonesia	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiorespiratory fitness	VO2Max in ml/kg/minute	12 weeks
Primary	body mass index	weight and height combined as BMI in kg/m2	week 4
Primary	body mass index	weight and height combined as BMI in kg/m2	week 8
Primary	body mass index	weight and height combined as BMI in kg/m2	week 12
Primary	body fat mass	total fat mass in the body as percentage	week 4
Primary	body fat mass	total fat mass in the body as percentage	week 8
Primary	body fat mass	total fat mass in the body as percentage	week 12
Primary	visceral fat	body fat stored within abdominal cavity as ratings	week 4
Primary	visceral fat	body fat stored within abdominal cavity as ratings	week 8
Primary	visceral fat	body fat stored within abdominal cavity as ratings	week 12
Primary	waist circumference	circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm	week 4
Primary	waist circumference	circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm	week 8
Primary	waist circumference	circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm	week 12
Primary	lipid profile	total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride	12 weeks
Primary	antioxidant level	SOD in U/mg	12 weeks
Primary	free radicals level	MDA in nmol/mg	12 weeks
Primary	inflammation	TNF-alpha in microgram/ml	12 weeks
Primary	interleukin level	IL-6 nanogram/ml	12 weeks
Secondary	Fat Burning Effect	FGF21	week 1, 6, 12
Secondary	Myokin	Irisin	week 1, 6, 12
Secondary	Cognitive Function Screening	Montreal Cognitive Assessment as score	week 1 and 12
Secondary	Working memory Capacity	N-Back test as percentage of correct answers	week 1 and 12
Secondary	Executive Function	Trail Making Test A and B as seconds	week 1 and 12