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Obesity & OverweightExerciseNCT07312344

Impact of Exercise-derived Extracellular Vesicle in Blood and Physical Fitness Data in Overweight/Obesity Individuals

A study testing High-intensity interval training exercise on treadmill in people with Obesity & Overweight, run by Mahidol University at 1 site in Thailand.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This project aims to study the effect of exercise in the obesity/overweight on the changes of physical fitness and blood components. This will provide novel knowledge for medical staffs, researchers, or companies developing alternative strategies for treating obesity/overweight, including drug development and health… Read more about this study

Who is it for?
Ages 25 to 45 years
Conditions the study is for
Obesity & Overweight
What is being tested?
High-intensity interval training exercise on treadmill
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteThailand
Study dates
30 Aug 2025to 31 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 25 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female individuals aged between 25-45 years
  • Thai nationality
  • Ability to walk or perform daily activities independently, without the use of an assistive device
  • Body mass index (BMI) between 25-35 kg/m²
  • Low physical activity levels or sedentary lifestyle based on the World Health Organization 2020
  • The levels of moderate-intensity physical activity < 150-300 minutes per week or the levels of vigorous-intensity physical activity < 75-150 minutes per week
  • Moderate-intensity physical activity: fast walking and bicycling. Vigorous-intensity physical activity: running, aerobic dance, and swimming All participants are required to meet all inclusion criteria to be eligible for the research project.

Who cannot join

  • Smoking, substance abuse, or alcohol addiction
  • History of respiratory diseases, such as asthma, emphysema, or chronic obstructive pulmonary disease
  • History of cardiovascular diseases, such as coronary heart disease, aortic disease, arrhythmia, or deep vein thrombosis
  • History of high blood pressure (hypertension)
  • History of vestibular system diseases, such as Meniere's disease or otitis media
  • History of neurological disease, such as severe Parkinson's disease or stroke
Show all 12Show fewer
  • History of previous lower limb surgery, such as hip, knee, or ankle replacement
  • History of musculoskeletal diseases, such as severe osteoarthritis
  • History of severe brain disease, such as dementia
  • Severe visual or hearing impairment
  • Have a cognitive and comprehensive impairment and unable to complete the intervention
  • Have high physical activity or regularly exercise

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Onaong Mee-inta, Ph.D. contact

(66)619922941

onanong.mee@mahidol.ac.th

Phunsuk Kantha, Ph.D. contact

(66)932951646

phunsuk.kan@mahidol.ac.th

Thailand1 site, 1 recruiting

  • Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital

    Mueang Samut Prakan, 10540

    Recruiting

Other trials in Thailand

About this study

Official title: Exploring the Impact of Exercise-derived Extracellular Vesicle in Blood and Physical Fitness Data in Overweight/Obesity Individuals on Lymphangiogenesis

This project aims to study the effect of exercise in the obesity/overweight on the changes of physical fitness and blood components. This will provide novel knowledge for medical staffs, researchers, or companies developing alternative strategies for treating obesity/overweight, including drug development and health promotion project to delay or prevent the onset of the disease.

Being tested
High-intensity interval training exercise on treadmill
Keywords
Exercise, obesity, extracellular vesicle, clinical assessment, physical fitness
Medical subject headings
Obesity, Overweight, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity interval training exercise on treadmillDevice

    Also called HIIT, treadmill running

    High-intensity interval training exercise using 65% to 80% of heart rate max

Study groups in NCT07312344
Study groupRoleWhat they receive
High-intensity interval training exerciseExperimentalHigh-intensity interval training exercise 3 days per week for 6 weeks
Receives: Device: High-intensity interval training exercise on treadmill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood component assessment

    Participant's blood components, e.g. extracellular vesicles, will be investigated by cell assays and proteomic analysis

    Measured: Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program within 1 hour)

  2. Foot pressure distribution

    Foot pressure distribution will be measured using a treadmill (Zebris FDM-T Treadmill System, zebris Medical GmbH, Germany)

    Measured: 8 times: Day 1 (Before and after HIIT program), Day 4-7 (after HIIT program only), Day 18 (Before and after HIIT program)

  3. Facial and abdominal fat thickness measurement

    Facial and abdominal fat thickness and characteristics will be pictured and analyzed using ultrasound imaging

    Measured: Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)

  4. VO2max

    VO2max parameter (ml/kg/min) will be examined using Cardio Pulmonary Exercise Test

    Measured: Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)

  5. Body composition

    Body composition (%) will be measured by bioelectrical impedance analysis.

    Measured: Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)

  6. Heart rate

    Heart rate (beat/min) will be measured by pulse oximeters

    Measured: Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)

  7. Grip strength

    Grip strength (kg) will be measured by hand grip dynamometer

    Measured: Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)

  8. Leg strength

    Leg strength (kg) will be measured by back-leg-chest dynamometer

    Measured: Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)

  9. Body weight

    Body weight (kg) will be measured by weighing scale

    Measured: Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)

  10. Body height

    Body height (cm) will be measured by stadiometer

    Measured: Pre-training (Day 1 before HIIT program)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2025
  2. Study start30 Aug 2025
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07312344
Sponsor's protocol ID
MURA2025/678
Other IDs
2025/1365
Acronym
Exercise
Status last verified
Dec 2025
First submitted
30 Nov 2025
Last updated
31 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gremeaux V, Drigny J, Nigam A, Juneau M, Guilbeault V, Latour E, Gayda M. Long-term lifestyle intervention with optimized high-intensity interval training improves body composition, cardiometabolic risk, and exercise parameters in patients with abdominal obesity. Am J Phys Med Rehabil. 2012 Nov;91(11):941-50. doi: 10.1097/PHM.0b013e3182643ce0.

    PubMed 22854902

  • Ryan BJ, Schleh MW, Ahn C, Ludzki AC, Gillen JB, Varshney P, Van Pelt DW, Pitchford LM, Chenevert TL, Gioscia-Ryan RA, Howton SM, Rode T, Hummel SL, Burant CF, Little JP, Horowitz JF. Moderate-Intensity Exercise and High-Intensity Interval Training Affect Insulin Sensitivity Similarly in Obese Adults. J Clin Endocrinol Metab. 2020 Aug 1;105(8):e2941-59. doi: 10.1210/clinem/dgaa345.

    PubMed 32492705

  • Turk Y, Theel W, Kasteleyn MJ, Franssen FME, Hiemstra PS, Rudolphus A, Taube C, Braunstahl GJ. High intensity training in obesity: a Meta-analysis. Obes Sci Pract. 2017 May 29;3(3):258-271. doi: 10.1002/osp4.109. eCollection 2017 Sep.

    PubMed 29071102

  • He XF, Liu DX, Zhang Q, Liang FY, Dai GY, Zeng JS, Pei Z, Xu GQ, Lan Y. Voluntary Exercise Promotes Glymphatic Clearance of Amyloid Beta and Reduces the Activation of Astrocytes and Microglia in Aged Mice. Front Mol Neurosci. 2017 May 19;10:144. doi: 10.3389/fnmol.2017.00144. eCollection 2017.

    PubMed 28579942

  • Aspelund A, Antila S, Proulx ST, Karlsen TV, Karaman S, Detmar M, Wiig H, Alitalo K. A dural lymphatic vascular system that drains brain interstitial fluid and macromolecules. J Exp Med. 2015 Jun 29;212(7):991-9. doi: 10.1084/jem.20142290. Epub 2015 Jun 15.

    PubMed 26077718

  • Louveau A, Smirnov I, Keyes TJ, Eccles JD, Rouhani SJ, Peske JD, Derecki NC, Castle D, Mandell JW, Lee KS, Harris TH, Kipnis J. Structural and functional features of central nervous system lymphatic vessels. Nature. 2015 Jul 16;523(7560):337-41. doi: 10.1038/nature14432. Epub 2015 Jun 1.

    PubMed 26030524

  • Secker GA, Harvey NL. VEGFR signaling during lymphatic vascular development: From progenitor cells to functional vessels. Dev Dyn. 2015 Mar;244(3):323-31. doi: 10.1002/dvdy.24227. Epub 2014 Dec 4.

    PubMed 25399804

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity interval training exercise on treadmill in people with Obesity & Overweight, run by Mahidol University at 1 site in Thailand.

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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. 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 Thailand. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Onaong Mee-inta, Ph.D. ((66)619922941, onanong.mee@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood component assessment (time frame: Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program within 1 hour)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07312344, which also lists 7 linked publications.

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 31 Dec 2025.

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