NCT05838950

Brief Summary

The primary aim of this randomized clinical trial is to compare the effects of three different HIIT protocols and a control group on cardiometabolic health in young adults with obesity. Participants will be randomly assigned to one of the following three groups, with each having varying work-to-rest ratios: 1) HIIT-A, 2) HIIT-B, 3) HIIT-C, and 4) control group. HIIT-A, HIIT-B, and HIIT-C groups will participate in six sessions of a running based HIIT program over a 2-week training period. Pre-clinical markers of cardiovascular disease, blood lipids and fasting glucose will be measured at the following three time points: baseline, post-intervention, and 2 weeks after the training cessation (i.e., measure for detraining effect). All measurements will be performed three days before the training program and three days after the intervention to avoid the effect of the last training session. Afterwards, the detraining test will be measured 2 weeks post intervention.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 29, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

February 13, 2023

Last Update Submit

July 17, 2025

Conditions

Keywords

HIITDetraining effectsCardiometabolic diseaseObesityYoung adults

Outcome Measures

Primary Outcomes (16)

  • Height

    Height (cm)

    Baseline

  • Weight

    Weight (kg); Change from Baseline weight at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Body mass index

    Body mass index (kg/m2); Change from Baseline BMI at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Percentage body fat

    Percentage body fat (kg); Change from Baseline percentage body fat at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Fat mass

    Fat mass (kg); Change from Baseline fat mass at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Lean mass

    Lean mass (kg); Change from Baseline lean mass at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Systolic blood pressure

    Systolic blood pressure (SBP, mmHg); Change from Baseline SBP at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Diastolic blood pressure

    Diastolic blood pressure (DBP, mmHg); Change from Baseline DBP at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Mean arterial pressure

    Mean blood pressure (MAP, mmHg); Change from Baseline MAP at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Flow-mediated dilation

    Flow-mediated dilation (FMD, mm); Change from Baseline FMD at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Carotid-femoral Pulse Wave Velocity (cPWV)

    cPWV (m/s); Change from Baseline cPWV at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Total cholesterol

    Total cholesterol (mg/dl); Change from Baseline TC at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • LDL-C

    LDL-C (mg/dl); Change from Baseline LDL-C at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • HDL-C

    HDL-C (mg/dl); Change from Baseline HDL-C at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Triglycerides

    Triglycerides (TG, mg/dl); Change from Baseline TG at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

  • Glucose

    Glucose (mg/dl); Change from Baseline glucose at 2 week and 4 week

    Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

Study Arms (4)

5s HIIT

EXPERIMENTAL

5s HIIT group will perform one bout of sprint running for 5-seconds followed by 25-second, resting of total 40 repetition.

Other: high-intensity interval training intervention

10s HIIT

EXPERIMENTAL

10s HIIT group will perform one bout of sprint running for 10-seconds followed by 50-second, resting of total 20 repetition.

Other: high-intensity interval training intervention

20s HIIT

EXPERIMENTAL

20s HIIT group will perform one bout of sprint running for 20-seconds followed by 100-second, resting of total 10 repetition.

Other: high-intensity interval training intervention

Control

EXPERIMENTAL

Control group

Other: high-intensity interval training intervention

Interventions

Intervention groups include 3 arms with 3 different HIIT protocols to identify optimal exercise regimen for improving cardiometabolic health in young adults with obesity.

10s HIIT20s HIIT5s HIITControl

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Young adults with obesity (Age 18 to 25 years old, BMI ≥ 30 kg/m2).

You may not qualify if:

  • Syndromic obesity; 1) Any clinical symptoms including cognitive delay, 2) abnormalities in body structure(s), 3) organ-specific abnormalities (kidney, liver failure, excessive eating, and/or other signs of hypothalamic dysfunction such as fatigue, weakness and/or lack of interest in activities.
  • Taking weight loss medication(s)
  • Currently enrolled (or within previous 6 months) in a weight loss program;
  • An underlying disease/medications (steroids, second generation psychotropic agents, hormonal contraception, statins, antihypertensive and antidiabetic medications) that could influence carbohydrate or lipid metabolism.
  • Presence of cardiac pacemaker.
  • Current or anticipated participation in another research that would interfere with any of the outcomes.
  • Current or anticipated pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Building

Syracuse, New York, 13244, United States

RECRUITING

MeSH Terms

Conditions

ObesityCardiovascular DiseasesMetabolic Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joon Young Kim, Ph.D

    Syracuse University, Departments of Exercise Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myong Won Seo, Ph.D

CONTACT

Wonhee Cho, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

May 3, 2023

Study Start

September 29, 2023

Primary Completion

August 23, 2025

Study Completion

December 10, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations