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NCT Number: NCT07312344

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

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.

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Key information

Conditions

Obesity & Overweight Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital

Mueang Samut Prakan, 10540, Thailand

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

High-intensity interval training exercise on treadmill

Device

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

Other names: HIIT, treadmill running

Primary outcomes

  1. Blood component assessment

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

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

  2. Foot pressure distribution

    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)

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

  3. Facial and abdominal fat thickness measurement

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

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

  4. VO2max

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

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

  5. Body composition

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

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

  6. Heart rate

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

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

  7. Grip strength

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

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

  8. Leg strength

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

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

  9. Body weight

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

    Body weight (kg) will be measured by weighing scale

  10. Body height

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

    Body height (cm) will be measured by stadiometer

Study contacts

Contact information is provided by the study sponsor or research team.

Onaong Mee-inta, Ph.D.

CONTACT

[email protected]

(66)619922941

Phunsuk Kantha, Ph.D.

CONTACT

[email protected]

(66)932951646

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Acronym: Exercise

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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