Metabolic SyndromeNCT06664398
Preventive Effects of Different Volumes of High-Intensity Interval Training on Risk Factors for MS in Overweight Young Women
A study testing one HIIT and four HIIT in people with Metabolic Syndrome, run by Beijing Sport University at 1 site in China.
Trial summary
This study investigates the effects of different volumes of high-intensity interval training on risk factors for metabolic syndrome in overweight young women. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- one HIIT and four HIIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2021to 30 Nov 2021
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-30 years;
- BMI≥24kg/m2, indicating overweight and high risk of metabolic syndrome;
- Maintaining a stable body weight for the three months prior to the study.
Who cannot join
- Regular participation in physical exercise (≥3 times/week, exercise time≥30min/time);
- Any respiratory, musculoskeletal, or cardiovascular diseases;
- Medical or other contraindications for exercise;
- Taking medications that affect metabolism;
- Smoking and/or drinking habits.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Sports Medicine and Rehabilitation, Beijing Sport University
Beijing
About this study
Official title: Preventive Effects of Different Volumes of High-Intensity Interval Training on Risk Factors for Metabolic Syndrome in Overweight Young Women
This study investigates the effects of different volumes of high-intensity interval training on risk factors for metabolic syndrome in overweight young women.
Read the detailed description
The sedentary and inactive female overweight subjects, aged 18 to 30 years, were randomly divided into three groups: high volume high-intensity interval training group (4HIIT group), low volume high-intensity interval training group (1HIIT group) and control group (CON group). Human morphological measures, blood pressure, insulin resistance, blood analysis, and cardiorespiratory fitness were measured at baseline and after exercise intervention.
- Conditions
- Metabolic Syndrome
- Being tested
- one HIIT, four HIIT
- Keywords
- high-intensity interval training, overweight, metabolic syndrome, risk factor, prevention
- Medical subject headings
- Metabolic Syndrome, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one HIITBehavioural
one HIIT high intensity interval training
four HIITBehavioural
four HIIT high intensity interval training
| Study group | Role | What they receive |
|---|---|---|
| 1HIIT group | Active comparator | Not described Receives: Behavioral: one HIIT |
| 4HIIT group | Active comparator | Not described Receives: Behavioral: four HIIT |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Changes in Weight before and after intervention.
Measured: 8 weeks
Body Mass Index (BMI)
Changes in BMI before and after intervention.
Measured: 8 weeks
body fat percentage
Changes in body fat percentage before and after intervention.
Measured: 8 weeks
waist circumference (WC)
Changes in WC before and after intervention.
Measured: 8 weeks
Systolic blood pressure (SBP)
Changes in SBP before and after intervention.
Measured: 8 weeks
Diastolic blood pressure (DBP)
Changes in DBP before and after intervention.
Measured: 8 weeks
Fasting plasma glucose (FPG)
Changes in FPG before and after intervention.
Measured: 8 weeks
Triglyceride (TG)
Changes in TG before and after intervention.
Measured: 8 weeks
High-density lipoprotein cholesterol (HDL-C)
Changes in HDL-C before and after intervention.
Measured: 8 weeks
Secondary outcomes (6)
Non high-density lipoprotein cholesterol (Non HDL-C)
Changes in HDL-C before and after intervention.
Measured: 8 weeks
Insulin
Changes in insulin before and after intervention.
Measured: 8 weeks
Homeostatic model assessment for insulin resistance (HOMA-IR)
12、Homeostatic model assessment for insulin resistance (HOMA-IR) Changes in HOMA-IR before and after intervention.
Measured: 8 weeks
Triglyceride-glucose (TyG) index
Changes in TyG index before and after intervention.
Measured: 8 weeks
Triglyceride-to-high density lipoprotein cholesterol ratio (TG/HDL-C ratio)
Changes in TG/HDL-C ratio before and after intervention.
Measured: 8 weeks
Visceral fat area (VFA)
Changes in VFA before and after intervention.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start14 Apr 2021
- Primary completion30 Jul 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664398
- Sponsor's protocol ID
- PEDVHIITRFMOYW
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 29 Oct 2024
- 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 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effects of Different Volumes of High-Intensity Interval Training on Risk Factors for Metabolic Syndrome in Overweight Young Women
- ClinicalTrials.gov ID
- NCT06664398
- Acronym / sponsor ID
- PEDVHIITRFMOYW
- Conditions
- Metabolic Syndrome
- Keywords
- high-intensity interval training, overweight, metabolic syndrome, risk factor, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 29 Oct 2024 (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.
This study investigates the effects of different volumes of high-intensity interval training on risk factors for metabolic syndrome in overweight young women.
Detailed description
The sedentary and inactive female overweight subjects, aged 18 to 30 years, were randomly divided into three groups: high volume high-intensity interval training group (4HIIT group), low volume high-intensity interval training group (1HIIT group) and control group (CON group). Human morphological measures, blood pressure, insulin resistance, blood analysis, and cardiorespiratory fitness were measured at baseline and after exercise intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1HIIT group | Active comparator | Behavioral: one HIIT |
| 4HIIT group | Active comparator | Behavioral: four HIIT |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-30 years;
- BMI≥24kg/m2, indicating overweight and high risk of metabolic syndrome;
- Maintaining a stable body weight for the three months prior to the study.
Key exclusion criteria (5 listed)
- Regular participation in physical exercise (≥3 times/week, exercise time≥30min/time);
- Any respiratory, musculoskeletal, or cardiovascular diseases;
- Medical or other contraindications for exercise;
- Taking medications that affect metabolism;
- Smoking and/or drinking habits.
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 |
|---|---|---|
| one HIITone HIIT high intensity interval training | Behavioural | 1HIIT group |
| four HIITfour HIIT high intensity interval training | Behavioural | 4HIIT group |
Primary outcome
Weight
Time frame: 8 weeks
Changes in Weight before and after intervention.
Body Mass Index (BMI)
Time frame: 8 weeks
Changes in BMI before and after intervention.
body fat percentage
Time frame: 8 weeks
Changes in body fat percentage before and after intervention.
waist circumference (WC)
Time frame: 8 weeks
Changes in WC before and after intervention.
Systolic blood pressure (SBP)
Time frame: 8 weeks
Changes in SBP before and after intervention.
Diastolic blood pressure (DBP)
Time frame: 8 weeks
Changes in DBP before and after intervention.
Fasting plasma glucose (FPG)
Time frame: 8 weeks
Changes in FPG before and after intervention.
Triglyceride (TG)
Time frame: 8 weeks
Changes in TG before and after intervention.
High-density lipoprotein cholesterol (HDL-C)
Time frame: 8 weeks
Changes in HDL-C before and after intervention.
6 secondary outcomes
Non high-density lipoprotein cholesterol (Non HDL-C)
Time frame: 8 weeks
Insulin
Time frame: 8 weeks
Homeostatic model assessment for insulin resistance (HOMA-IR)
Time frame: 8 weeks
Triglyceride-glucose (TyG) index
Time frame: 8 weeks
Triglyceride-to-high density lipoprotein cholesterol ratio (TG/HDL-C ratio)
Time frame: 8 weeks
Visceral fat area (VFA)
Time frame: 8 weeks
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 29 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one HIIT and four HIIT in people with Metabolic Syndrome, run by Beijing Sport University at 1 site in China.
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 5 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 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Weight (time frame: 8 weeks). The study lists 9 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 29 Oct 2024.