Recruiting

HIIT & TRE

Sponsor:

Syracuse University

Code:

NCT07215533

Conditions

Obesity and Type 2 Diabetes

Metabolic Diseases

High-intensity Interval Training

Time-restricted Eating

Eligibility Criteria

Sex: All

Age: 14 - 30

Healthy Volunteers: Accepted

Interventions

High-intensity interval training

Time-restricted eating

Study Details

Brief summary:

The primary aim of this randomized controlled trial is to examine the effects of a 4-week high-intensity interval training (HIIT) and time-restricted eating (TRE) intervention on cardiometabolic biomarkers in adolescents and young adults.

Conditions

Obesity and Type 2 Diabetes

Metabolic Diseases

High-intensity Interval Training

Time-restricted Eating

Study ID

NCT07215533

Start date

Mar 15, 2024

Status verified date

Oct, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 30

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adolescents (age 14-17 years old with sex- and race-specific BMI percentile ≥85th) and young adults with overweight and obesity (age 18 to 30 years old with BMI ≥25 kg/m2)

Exclusion Criteria:

  • Chronic medical conditions: heart disease, arrhythmias, diabetes, thyroid disease, bleeding disorder, history of pulmonary disease, hypertension, hepatorenal disease, musculoskeletal disorder, neuromuscular/neurological disease, autoimmune disease, cancer, peptic ulcers, anemia, or chronic infection (HIV).
  • Have taken any heart, pulmonary, thyroid, anti-hyperlipidemic, hypoglycemic, anti- hypertensive, endocrinologic (e.g., thyroid, insulin, etc.), emotional/psychotropic (e.g., Prednisone, Ritalin, Adderall), neuromuscular/neurological, or androgenic medications (anabolic steroids).
  • Have a pacemaker.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: High-intensity interval training

HIIT: The 4-week HIIT intervention will use a stationary bicycle performed 3 times/week (a total of 12 sessions over the 4-week), performing at the CRL. All participants will perform a 20-minute HIIT protocol (20 repetitions of 10-seconds work time followed by 50-seconds resting/active recovery for the first two weeks, and 10 repetitions of 20-seconds work time followed by 100-seonds resting/active recovery for the rest of two weeks; targeted 90% HRmax) after 5-minute warm-up (10% HRmax). The supervisor (PI: Joon Young Kim and/or Graduate researcher: Wonhee Cho) will provide encouragement and supervision for exercise adherence. Heart rate (Polar, Polar Electro Oy, Kempele, Finland) and rating of perceived exertion (RPE; detail described in the questionnaire section) will be recorded.

experimental: Time-restricted eating

Participants randomized into the TRE group will be instructed to consume all their calories within a 10-hour period. We will instruct participants that they can choose their time-window (early TRE \[7am - 5pm\] or late TRE \[1pm - 11pm\]), but it must remain constant for the duration of the study. Further, we will give no restrictions on the type of foods and/or the quantities individuals can consume. We will ask individuals to maintain their diet for the duration of the study. Participants will be given clear instructions on their diet and how to use the "MyFitnessPal" application. Participants will have their total daily energy requirement calculated using the following formula (Basal metabolic rate \[BMR\] x activity level) and will be told to eat that amount within their allotted time window. BMR will be calculated when participants have their body composition taken by the InBody. Participants will be told to start their 4-week diet the following day after visit.

no intervention: Control Group

Participants randomized into the control group will be told to maintain their daily lifestyle and dietary habits for the duration of the four weeks.

Interventions

High-intensity interval training

The 4-week HIIT intervention will use a stationary bicycle performed 3 times/week (a total of 12 sessions over the 4-week), performing at the CRL. All participants will perform a 20-minute HIIT protocol (20 repetitions of 10-seconds work time followed by 50-seconds resting/active recovery for the first two weeks, and 10 repetitions of 20-seconds work time followed by 100-seonds resting/active recovery for the rest of two weeks; targeted 90% HRmax) after 5-minute warm-up (10% HRmax). The supervisor (PI: Joon Young Kim and/or Graduate researcher: Wonhee Cho) will provide encouragement and supervision for exercise adherence. Heart rate (Polar, Polar Electro Oy, Kempele, Finland) and rating of perceived exertion (RPE; detail described in the questionnaire section) will be recorded.

Time-restricted eating

Participants randomized into the TRE group will be instructed to consume all their calories within a 10-hour period. We will instruct participants that they can choose their time-window (early TRE \[7am - 5pm\] or late TRE \[1pm - 11pm\]), but it must remain constant for the duration of the study. Further, we will give no restrictions on the type of foods and/or the quantities individuals can consume. We will ask individuals to maintain their diet for the duration of the study. Participants will be given clear instructions on their diet and how to use the "MyFitnessPal" application. Participants will have their total daily energy requirement calculated using the following formula (Basal metabolic rate \[BMR\] x activity level) and will be told to eat that amount within their allotted time window. BMR will be calculated when participants have their body composition taken by the InBody. Participants will be told to start their 4-week diet the following day after visit.

Primary outcome measure

  • Weight (kg) [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Height (cm) [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Body Mass Index (BMI) [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Waist Circumference and Hip Circumference [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Blood Lipid Profile [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Blood Pressure [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Carotid-Femoral Pulse Wave Velocity [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Glucose (mg/dL) [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Insulin (μIU/mL) [ Time Frame: Baseline and after 4 weeks of intervention ]
  • C-peptide (ng/mL) [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Total glucagon-like peptide-1 (GLP-1) (pmol/L) [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Glucose-dependent insulinotropic polypeptide (GIP) (pg/mL) [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Leptin (ng/mL) [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Adiponectin (μg/mL) [ Time Frame: Time Frame: Baseline and after 4 weeks of intervention ]
  • Ghrelin (pg/mL) [ Time Frame: Baseline and after 4 weeks of intervention ]
  • C-reactive protein (CRP) (mg/L) [ Time Frame: Baseline and after 4 weeks of intervention ]
  • Interleukin-6 (IL-6) (pg/mL) [ Time Frame: Baseline and after 4 weeks of intervention ]

Central Contacts and Locations

Central contacts

Wonhee Cho, MS, PhD Candidate

+16267270270wcho02@syr.edu

Joon Young Kim, PhD, PhD

jkim291@syr.edu

Locations

Syracuse University

Recruiting

Syracuse, New York, United States, 13244

Contacts

Joon Young Kim, PhD

315-443-2115jkim291@syr.edu

Principal Investigator:

Joon Young Kim, PhD

More Information

Sponsor

Syracuse University

Last update posted

Oct 10, 2025

Last verified

Oct, 2025

Keywords

  • High-intensity Interval Training
  • Time-restricted Eating
  • Obesity
  • Type 2 Diabetes
  • Youth
  • Young Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Syracuse University on 2025-10-10.