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

NCT07312344 | Recruiting

• 2 other identifiers: MURA2025/6782025/1365
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight

Keywords

Exercise; obesity; extracellular vesicle; clinical assessment; physical fitness

Outcome Measures

Primary Outcomes (10)

• 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)

Study Arms (1)

High-intensity interval training exercise

EXPERIMENTAL

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

Device: High-intensity interval training exercise on treadmill

Interventions

High-intensity interval training exercise on treadmill DEVICE

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

Also known as: HIIT, treadmill running

High-intensity interval training exercise

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital

Mueang Samut Prakan, 10540, Thailand

RECRUITING

Related Publications (7)

• 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.

  PMID: 22854902 BACKGROUND

• 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.

  PMID: 32492705 BACKGROUND

• 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.

  PMID: 29071102 BACKGROUND

• 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.

  PMID: 28579942 BACKGROUND

• 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.

  PMID: 26077718 BACKGROUND

• 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.

  PMID: 26030524 BACKGROUND

• 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.

  PMID: 25399804 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 31, 2025
• Study Start: August 30, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)