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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity & Overweight
• Intervention / Treatment: Device: High-intensity interval training exercise on treadmill

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Onaong Mee-inta, Ph.D.; Phone Number: (66)619922941; Email: onanong.mee@mahidol.ac.th
• Study Contact Backup: Name: Phunsuk Kantha, Ph.D.; Phone Number: (66)932951646; Email: phunsuk.kan@mahidol.ac.th

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; High-intensity interval training exercise using 65% to 80% of heart rate max; Other Names: HIIT; treadmill running

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood component assessment	Participant's blood components, e.g. extracellular vesicles, will be investigated by cell assays and proteomic analysis	Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program within 1 hour)
Foot pressure distribution	Foot pressure distribution will be measured using a treadmill (Zebris FDM-T Treadmill System, zebris Medical GmbH, Germany)	8 times: Day 1 (Before and after HIIT program), Day 4-7 (after HIIT program only), Day 18 (Before and after HIIT program)
Facial and abdominal fat thickness measurement	Facial and abdominal fat thickness and characteristics will be pictured and analyzed using ultrasound imaging	Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)
VO2max	VO2max parameter (ml/kg/min) will be examined using Cardio Pulmonary Exercise Test	Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)
Body composition	Body composition (%) will be measured by bioelectrical impedance analysis.	Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)
Heart rate	Heart rate (beat/min) will be measured by pulse oximeters	Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)
Grip strength	Grip strength (kg) will be measured by hand grip dynamometer	Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)
Leg strength	Leg strength (kg) will be measured by back-leg-chest dynamometer	Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)
Body weight	Body weight (kg) will be measured by weighing scale	Pre-training (Day 1 before HIIT program) and post-training (Day 18 after HIIT program)
Body height	Body height (cm) will be measured by stadiometer	Pre-training (Day 1 before HIIT program)

Collaborators and Investigators

• Sponsor: Mahidol University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; obesity; clinical assessment; physical fitness; extracellular vesicle
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Motor Activity
• Other Study ID Numbers: MURA2025/678; 2025/1365 (Registry Identifier: Mahidol University Multi-faculty Cooperative IRB Review)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No