OverweightNCT05000437
The Effectiveness and Safety of HIIT in Overweight Male Subjects
A study testing HIIT in people with Overweight and Overweight or Obesity, run by Universitas Indonesia at 2 sites in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Overweight or Obesity
- What is being tested?
- HIIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesIndonesia
- Study dates
- 1 Nov 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- overweight (BMI 25 - 29,9)
- live in Jakarta and greater area
- willing to participate
Who cannot join
- smoking
- any medical health problems (epilepsy, cardiovascular disease, kidney and liver problems, history of fractures, tendon and ligament injuries)
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
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
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.
Read the 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.
- Conditions
- Overweight, Overweight or Obesity
- Being tested
- HIIT
- Keywords
- high intensity interval training, overweight, young male
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITOther
3x/week high intensity interval training for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | single arm intervention, with high intensity interval training Receives: Other: HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiorespiratory fitness
VO2Max in ml/kg/minute
Measured: 12 weeks
body mass index
weight and height combined as BMI in kg/m2
Measured: week 4
body mass index
weight and height combined as BMI in kg/m2
Measured: week 8
body mass index
weight and height combined as BMI in kg/m2
Measured: week 12
body fat mass
total fat mass in the body as percentage
Measured: week 4
body fat mass
total fat mass in the body as percentage
Measured: week 8
body fat mass
total fat mass in the body as percentage
Measured: week 12
visceral fat
body fat stored within abdominal cavity as ratings
Measured: week 4
visceral fat
body fat stored within abdominal cavity as ratings
Measured: week 8
visceral fat
body fat stored within abdominal cavity as ratings
Measured: week 12
waist circumference
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
Measured: week 4
waist circumference
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
Measured: week 8
waist circumference
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
Measured: week 12
lipid profile
total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride
Measured: 12 weeks
antioxidant level
SOD in U/mg
Measured: 12 weeks
free radicals level
MDA in nmol/mg
Measured: 12 weeks
inflammation
TNF-alpha in microgram/ml
Measured: 12 weeks
interleukin level
IL-6 nanogram/ml
Measured: 12 weeks
Secondary outcomes (5)
Fat Burning Effect
FGF21
Measured: week 1, 6, 12
Myokin
Irisin
Measured: week 1, 6, 12
Cognitive Function Screening
Montreal Cognitive Assessment as score
Measured: week 1 and 12
Working memory Capacity
N-Back test as percentage of correct answers
Measured: week 1 and 12
Executive Function
Trail Making Test A and B as seconds
Measured: week 1 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Nov 2020
- Primary completion30 Oct 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nani Cahyani Sudarsono, Universitas Indonesia
- Investigators
- Nani Sudarsono, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000437
- Sponsor's protocol ID
- 20-09-1081
- Status last verified
- Mar 2023
- First submitted
- 29 May 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05000437
- Acronym / sponsor ID
- 20-09-1081
- Conditions
- Overweight, Overweight or Obesity
- Keywords
- high intensity interval training, overweight, young male
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Other: HIITsingle arm intervention, with high intensity interval training |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- overweight (BMI 25 - 29,9)
- live in Jakarta and greater area
- willing to participate
Key exclusion criteria (2 listed)
- smoking
- any medical health problems (epilepsy, cardiovascular disease, kidney and liver problems, history of fractures, tendon and ligament injuries)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT3x/week high intensity interval training for 12 weeks | Other | High Intensity Interval Training |
Primary outcome
cardiorespiratory fitness
Time frame: 12 weeks
VO2Max in ml/kg/minute
body mass index
Time frame: week 4
weight and height combined as BMI in kg/m2
body mass index
Time frame: week 8
weight and height combined as BMI in kg/m2
body mass index
Time frame: week 12
weight and height combined as BMI in kg/m2
body fat mass
Time frame: week 4
total fat mass in the body as percentage
body fat mass
Time frame: week 8
total fat mass in the body as percentage
body fat mass
Time frame: week 12
total fat mass in the body as percentage
visceral fat
Time frame: week 4
body fat stored within abdominal cavity as ratings
visceral fat
Time frame: week 8
body fat stored within abdominal cavity as ratings
visceral fat
Time frame: week 12
body fat stored within abdominal cavity as ratings
waist circumference
Time frame: week 4
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
waist circumference
Time frame: week 8
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
waist circumference
Time frame: week 12
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
lipid profile
Time frame: 12 weeks
total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride
antioxidant level
Time frame: 12 weeks
SOD in U/mg
free radicals level
Time frame: 12 weeks
MDA in nmol/mg
inflammation
Time frame: 12 weeks
TNF-alpha in microgram/ml
interleukin level
Time frame: 12 weeks
IL-6 nanogram/ml
5 secondary outcomes
Fat Burning Effect
Time frame: week 1, 6, 12
Myokin
Time frame: week 1, 6, 12
Cognitive Function Screening
Time frame: week 1 and 12
Working memory Capacity
Time frame: week 1 and 12
Executive Function
Time frame: week 1 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nani Sudarsono principal investigator
Fakultas Kedokteran Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT in people with Overweight and Overweight or Obesity, run by Universitas Indonesia at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiorespiratory fitness (time frame: 12 weeks). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.