Overweight or ObesityHIITNCT06383442
HIIT on Overweight Middle-aged Adults
A study testing L-HIIT and M-HIIT in people with Overweight or Obesity, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
36 middle-aged with overweight adults were divided into three groups: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise/2 min Rest), 3. Control group: no exercise intervention. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- L-HIIT and M-HIIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 May 2021to 22 Nov 2023
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recruit people who are overweight or obese (BMI between 24-35) who are 20-65 years old and have no exercise habits in a sitting lifestyle.
Who cannot join
- If there are any of the following circumstances, they are not allowed to participate in this research and are included in the listing conditions of this case:
- Have smoking and drinking habits.
- People who have stroke, type 1 and type 2 diabetes, neuromuscular disease, so that they cannot participate in physical activities.
- Chronic obstructive lung disease, asthma, interstitial lung disease or alveolar cyst fibrosis.
- Metabolic diseases include thyroid disease, kidney disease (kidney, bladder stones) or liver disease.
- Those with arrhythmia, a rhythm regulator, severe cardiovascular disease, peripheral vascular disease or cerebrovascular disease.
Show all 15Show fewer
- People with epilepsy and rheumatoid arthritis.
- Those who have implanted artificial joints in the past six months and have had recent surgery.
- Migraine, acute thrombosis and hernia.
- Those who have engaged in strenuous exercise or have muscle aches within 24 hours before the experiment.
- People who feel unwell due to other reasons during the experiment.
- People with severe food allergies.
- Have hospitalization records within three months.
- People with cognitive impairment.
- Take any drugs that affect the function of the nervous system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Types of High Intensity Intermittent Training Combined With Resveratrol Supplementation on Oxidative Stress, Metabolic Adaption and Fat Loss in Aged and Overweight Groups
36 middle-aged with overweight adults were divided into three groups: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise/2 min Rest), 3. Control group: no exercise intervention. All groups carried out the training stage for 8 weeks (three sessions per week) and the detraining stage for 4 weeks in order to investigate the effects induced by different HIIT interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss.
Read the detailed description
Aging, obesity, have been shown to lead to higher oxidative stress and chronic inflammation. However, high-intensity interval training (HIIT) has anti-inflammatory and anti-obesity benefits. Different training prescriptions may also affect improvements. Therefore, this study will explore the optimal HIIT prescription to improve fat, inflammation, metabolism, and exercise performance in overweight middle-aged and older adults. Thirty-six middle-aged with overweight adults were divided into three groups: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise/2 min Rest), 3. Control group: no exercise intervention. All groups carried out the training stage for 8 weeks (three sessions per week), then the detraining stage for 4 weeks in order to investigate the effects induced by different HIIT interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss.
- Conditions
- Overweight or Obesity
- Being tested
- L-HIIT, M-HIIT
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-HIITOther
the long-interval HIIT group (4 × 4 min Exercise/4 min Rest)
M-HIITOther
the medium-interval HIIT group (8 × 2 min Exercise /2 min Rest)
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| M-HIIT | Experimental | Not described Receives: Other: M-HIIT |
| L-HIIT | Experimental | Not described Receives: Other: L-HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Capacity Test
a graded exercise test (GXT) was performed using a stationary bike ergometer (ergo_bike Premium 8i, Flugplatzstr, Germany) to assess the subject's VO2peak
Measured: Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Aerobic Capacity Test
All subjects wore polar heart rate belts (Polar Electro Oy, Kempele, Finland) to monitor maximum heart rate during aerobic capacity testing.
Measured: Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Anti-fatigue performance
After a standard warm-up, all subjects were assessed with the classical Wingate (WAnT) on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average relative mean power parameters were recorded.
Measured: Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
skinfold thickness
The sum of skinfold thickness at seven sites (triceps, chest, subscapular muscle, upper ilium, abdomen, front thigh, and leg) was measured by using a skinfold caliper (Beta Technology, Santa Cruz, California, USA).
Measured: Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Body composition_body fat
The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The body fat were meansure
Measured: Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Secondary outcomes (8)
Glucose
Safety is assessed function of Glucose (70~100 mg/dL)
Measured: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Triglycerides
Safety is assessed function of blood lipid such as Triglycerides (<150 mg/dL)
Measured: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
low-density lipoprotein (LDL)
Safety is assessed function of blood lipid such as LDL (0~140mg/dl)
Measured: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
high-density lipoprotein (HDL)
Safety is assessed function of blood lipid such as LDL (0~140mg/dl)
Measured: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
creatine kinase (CK) level
At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Assess serum CK(Creatine Kinase, U/L) to monitor physiological fitness. Serum CK (U/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
Measured: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
C-reactive protein (CRP)
At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Used commercial kit human CRP (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
Measured: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
tumor necrosis factor (TNF)-R1
At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Used commercial kit human TNF-R1 (R \& D SYSTEMS, MN USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
Measured: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
TNF-R2
At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Used commercial kit human TNF-R1 (R \& D SYSTEMS, MN USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
Measured: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start25 May 2021
- Primary completion31 Jul 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were evenly distributed according to a counterbalanced design and divided into three different groups by the body fat percentage of subjects: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise /2 min Rest), 3. Control group. Target intensities of each interval bout, exercise and rest (Ex./R.), were 85-90% VO2peak/65-70% VO2peak zones, respectively.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383442
- Sponsor's protocol ID
- N202103041
- Acronym
- HIIT
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Types of High Intensity Intermittent Training Combined With Resveratrol Supplementation on Oxidative Stress, Metabolic Adaption and Fat Loss in Aged and Overweight Groups
- ClinicalTrials.gov ID
- NCT06383442
- Acronym / sponsor ID
- HIIT / N202103041
- Conditions
- Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 25 Apr 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.
36 middle-aged with overweight adults were divided into three groups: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise/2 min Rest), 3. Control group: no exercise intervention. All groups carried out the training stage for 8 weeks (three sessions per week) and the detraining stage for 4 weeks in order to investigate the effects induced by different HIIT interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss.
Detailed description
Aging, obesity, have been shown to lead to higher oxidative stress and chronic inflammation. However, high-intensity interval training (HIIT) has anti-inflammatory and anti-obesity benefits. Different training prescriptions may also affect improvements. Therefore, this study will explore the optimal HIIT prescription to improve fat, inflammation, metabolism, and exercise performance in overweight middle-aged and older adults. Thirty-six middle-aged with overweight adults were divided into three groups: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise/2 min Rest), 3. Control group: no exercise intervention. All groups carried out the training stage for 8 weeks (three sessions per week), then the detraining stage for 4 weeks in order to investigate the effects induced by different HIIT interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were evenly distributed according to a counterbalanced design and divided into three different groups by the body fat percentage of subjects: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise /2 min Rest), 3. Control group. Target intensities of each interval bout, exercise and rest (Ex./R.), were 85-90% VO2peak/65-70% VO2peak zones, respectively.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| M-HIIT | Experimental | Other: M-HIIT |
| L-HIIT | Experimental | Other: L-HIIT |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recruit people who are overweight or obese (BMI between 24-35) who are 20-65 years old and have no exercise habits in a sitting lifestyle.
Key exclusion criteria (15 listed)
- If there are any of the following circumstances, they are not allowed to participate in this research and are included in the listing conditions of this case:
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 |
|---|---|---|
| L-HIITthe long-interval HIIT group (4 × 4 min Exercise/4 min Rest) | Other | L-HIIT |
| M-HIITthe medium-interval HIIT group (8 × 2 min Exercise /2 min Rest) | Other | M-HIIT |
Primary outcome
Aerobic Capacity Test
Time frame: Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
a graded exercise test (GXT) was performed using a stationary bike ergometer (ergo_bike Premium 8i, Flugplatzstr, Germany) to assess the subject's VO2peak
Aerobic Capacity Test
Time frame: Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
All subjects wore polar heart rate belts (Polar Electro Oy, Kempele, Finland) to monitor maximum heart rate during aerobic capacity testing.
Anti-fatigue performance
Time frame: Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
After a standard warm-up, all subjects were assessed with the classical Wingate (WAnT) on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average relative mean power parameters were recorded.
skinfold thickness
Time frame: Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
The sum of skinfold thickness at seven sites (triceps, chest, subscapular muscle, upper ilium, abdomen, front thigh, and leg) was measured by using a skinfold caliper (Beta Technology, Santa Cruz, California, USA).
Body composition_body fat
Time frame: Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The body fat were meansure
8 secondary outcomes
Glucose
Time frame: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Triglycerides
Time frame: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
low-density lipoprotein (LDL)
Time frame: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
high-density lipoprotein (HDL)
Time frame: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
creatine kinase (CK) level
Time frame: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
C-reactive protein (CRP)
Time frame: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
tumor necrosis factor (TNF)-R1
Time frame: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
TNF-R2
Time frame: were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 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 25 Apr 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 L-HIIT and M-HIIT in people with Overweight or Obesity, run by Taipei Medical University at 1 site in Taiwan.
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 1 inclusion and 15 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 25 Apr 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 Taiwan. 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?
Aerobic Capacity Test (time frame: Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).). The study lists 5 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 25 Apr 2024.