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RecruitingNCT07312344ExerciseUpdated Dec 31, 2025

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

An interventional study of High-intensity interval training exercise on treadmill in Obesity & Overweight, sponsored by Mahidol University. Recruiting at 1 site in Thailand. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by Mahidol University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Aug 2025, registered Nov 2025).
  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
25 Years to 45 Years
Sex
All
01

Study 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 promotion project to delay or prevent the onset of the disease.

02

Conditions studied

  • Obesity & Overweight

Keywords

  • Exercise
  • obesity
  • extracellular vesicle
  • clinical assessment
  • physical fitness
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 20 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female individuals aged between 25-45 years
  2. Thai nationality
  3. Ability to walk or perform daily activities independently, without the use of an assistive device
  4. Body mass index (BMI) between 25-35 kg/m²

  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. Smoking, substance abuse, or alcohol addiction
  2. History of respiratory diseases, such as asthma, emphysema, or chronic obstructive pulmonary disease
  3. History of cardiovascular diseases, such as coronary heart disease, aortic disease, arrhythmia, or deep vein thrombosis
  4. History of high blood pressure (hypertension)
  5. History of vestibular system diseases, such as Meniere's disease or otitis media
  6. History of neurological disease, such as severe Parkinson's disease or stroke
  7. History of previous lower limb surgery, such as hip, knee, or ankle replacement
  8. History of musculoskeletal diseases, such as severe osteoarthritis
  9. History of severe brain disease, such as dementia
  10. Severe visual or hearing impairment
  11. Have a cognitive and comprehensive impairment and unable to complete the intervention
  12. Have high physical activity or regularly exercise
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    High-intensity interval training exercise

    High-intensity interval training exercise 3 days per week for 6 weeks

    Device: High-intensity interval training exercise on treadmill

Interventions

  • DeviceHigh-intensity interval training exercise on treadmill

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

    Also known as: HIIT, treadmill running

06

What researchers measure

Primary outcomes

  1. Blood component assessment

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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Pre-training (Day 1 before HIIT program)

07

Study locations

1 of 1 sites recruiting
  • Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital
    Mueang Samut Prakan, 10540, Thailand
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07312344
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Dec 31, 2025
Start date
Aug 30, 2025
Primary completion
Jan 31, 2026 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Dec 31, 2025

Study contacts

Onaong Mee-inta, Ph.D.
Contact
onanong.mee@mahidol.ac.th
(66)619922941
Phunsuk Kantha, Ph.D.
Contact
phunsuk.kan@mahidol.ac.th
(66)932951646

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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