- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06383442
HIIT on Overweight Middle-aged Adults (HIIT)
April 24, 2024 updated by: Taipei Medical University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 110
- Taipei Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: M-HIIT
|
the medium-interval HIIT group (8 × 2 min Exercise /2 min Rest)
|
|
Experimental: L-HIIT
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the long-interval HIIT group (4 × 4 min Exercise/4 min Rest)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
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.
|
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
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.
|
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
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).
|
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
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Safety is assessed function of Glucose (70~100 mg/dL)
|
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).
|
Safety is assessed function of blood lipid such as Triglycerides (<150 mg/dL)
|
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).
|
Safety is assessed function of blood lipid such as LDL (0~140mg/dl)
|
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).
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Safety is assessed function of blood lipid such as LDL (0~140mg/dl)
|
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).
|
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).
|
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).
|
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
|
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).
|
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
|
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).
|
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
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2021
Primary Completion (Actual)
July 31, 2023
Study Completion (Actual)
November 22, 2023
Study Registration Dates
First Submitted
April 15, 2024
First Submitted That Met QC Criteria
April 24, 2024
First Posted (Actual)
April 25, 2024
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202103041
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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