Obesity and Type 2 DiabetesNCT07215533
Effects of HIIT vs. TRE on Type 2 Diabetes Risk
A study testing High-intensity interval training and Time-restricted eating in people with Obesity and Type 2 Diabetes and Metabolic Diseases, run by Syracuse University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Type 2 Diabetes, Metabolic Diseases, High-intensity Interval Training
- What is being tested?
- High-intensity interval training and Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joon Young Kim, PhD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Syracuse University
Syracuse, New York, 13244
Joon Young Kim, PhD, 315-443-2115, jkim291@syr.edu
Joon Young Kim, PhD
About this study
Official title: Differential Effects of HIIT vs. TRE on Type 2 Diabetes Risk in Youth and Younger Adults
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.
Read the detailed description
As of 2015, an estimated 2 billion individuals were overweight (body mass index [BMI] ≥ 25 kg/m2), and one-third of them were obese (BMI ≥ 30 kg/m2). Obesity has become a serious health concern due to its related comorbidities, including cardiovascular disease (CVD) and type 2 diabetes (T2D). While adolescents and young adults are considered low risk for the development of CVD, individuals with obesity are still at a greater risk of CVD development than individuals without obesity. Changes to dietary and fitness habits are currently the first-line recommendations for preventing weight gain and improving cardiometabolic health in adolescents and young adults.
Caloric restriction (CR), which involves reducing caloric intake by up to 50% of normal daily calorie intake, is a common dietary intervention approach for weight management and improving cardiometabolic health in adolescents and adults with obesity.9 However, studies have shown that CR is hard to maintain, and individuals tend to regain the weight after the intervention is completed. Time-restricted eating (TRE) has been proposed as an alternative to calorie restriction (CR). TRE, a type of short-term fasting, is defined as periods of no caloric intake followed by periods of ad libitum (as much as desired) caloric intake. The fact that TRE does not intentionally limit energy intake, whereas CR does, could make it more appealing to individuals in terms of adherence, acceptability, and efficacy. TRE is an effective strategy in reducing body fat percentage and waist circumference in adolescents and adults with obesity.
Moreover, high-intensity interval training (HIIT), which involves repeating short periods of intense activity followed by low-intensity breaks, has been shown to be effective in improving cardiometabolic health (including lipids, blood pressure, and insulin sensitivity) in adults with obesity compared to other traditional exercises. In addition to its benefits on cardiometabolic health, previous studies have suggested that HIIT can be a time-efficient strategy to enhance body composition and cardiopulmonary fitness in adults with obesity.1
However, it is unknown if TRE or HIIT will produce a greater improvement in cardiometabolic health. Therefore, the goal of this study is to examine the independent effect of a 4-week TRE and HIIT intervention on cardiometabolic biomarkers in youth and young adults.
- Conditions
- Obesity and Type 2 Diabetes, Metabolic Diseases, High-intensity Interval Training, Time-restricted Eating
- Being tested
- High-intensity interval training, Time-restricted eating
- Keywords
- High-intensity Interval Training, Time-restricted Eating, Obesity, Type 2 Diabetes, Youth, Young Adults
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Metabolic Diseases, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
Also called 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.
Time-restricted eatingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | 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. Receives: Behavioral: High-intensity interval training |
| Time-restricted eating | Experimental | 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. Receives: Behavioral: Time-restricted eating |
| Control Group | No intervention | Participants randomized into the control group will be told to maintain their daily lifestyle and dietary habits for the duration of the four weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (kg)
Weight is measured in kilograms (kg) using a calibrated digital scale.
Measured: Baseline and after 4 weeks of intervention
Height (cm)
Height is measured in centimeters (cm) using a wall-mounted stadiometer.
Measured: Baseline and after 4 weeks of intervention
Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m².
Measured: Baseline and after 4 weeks of intervention
Waist Circumference and Hip Circumference
Waist and hip circumferences are measured while participants stand straight with their arms extended outward. A non-elastic tape measure is wrapped around the waist and hip, and measurements are taken to the nearest centimeter (cm).
Measured: Baseline and after 4 weeks of intervention
Blood Lipid Profile
Blood lipid profile, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), and fasting glucose (FG) are measured in milligrams per deciliter (mg/dL) using the Cholestech LDX Analyzer. Blood samples are obtained via fingerstick, with the first drop wiped away and the second drop collected for analysis. Participants stand or sit comfortably during collection. After blood collection, the site is cleaned and covered with gauze and a bandage as needed. This procedure is minimally invasive and typically causes little discomfort.
Measured: Baseline and after 4 weeks of intervention
Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) are measured in millimeters of mercury (mmHg), and resting heart rate (RHR) is measured in beats per minute (bpm) using an automated blood pressure monitor. Participants sit quietly for five minutes with minimal movement prior to measurement. A cuff is placed on the right upper arm (bicep area), and the monitor initiates inflation, deflation, and reinflation cycles. Participants are instructed not to move during the measurement process. All equipment is disinfected before and after each use with antiviral, antibacterial, and antifungal disposable wipes by a researcher wearing gloves.
Measured: Baseline and after 4 weeks of intervention
Carotid-Femoral Pulse Wave Velocity
Carotid-femoral pulse wave velocity (PWV), a preclinical marker of cardiovascular disease (CVD), is measured in meters per second (m/s) using applanation tonometry (SphygmoCor, AtCor Medical). Participants are positioned supine on a padded exam table after resting quietly for approximately five minutes. Brachial blood pressure is measured in millimeters of mercury (mmHg) using an automated cuff device. Pressure waveforms are recorded at the carotid artery (neck) and femoral artery (upper leg) using a handheld tonometer. The time delay between carotid and femoral pulse waves is used to calculate PWV, an indicator of arterial stiffness. The procedure is non-invasive and typically requires approximately five minutes to complete.
Measured: Baseline and after 4 weeks of intervention
Glucose (mg/dL)
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of glucose (mg/dL).
Measured: Baseline and after 4 weeks of intervention
Insulin (μIU/mL)
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of insulin (μIU/mL).
Measured: Baseline and after 4 weeks of intervention
C-peptide (ng/mL)
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of C-peptide (ng/mL).
Measured: Baseline and after 4 weeks of intervention
Total glucagon-like peptide-1 (GLP-1) (pmol/L)
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of total glucagon-like peptide-1 (GLP-1) (pmol/L).
Measured: Baseline and after 4 weeks of intervention
Glucose-dependent insulinotropic polypeptide (GIP) (pg/mL)
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of glucose-dependent insulinotropic polypeptide (GIP) (pg/mL).
Measured: Baseline and after 4 weeks of intervention
Leptin (ng/mL)
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of leptin (ng/mL).
Measured: Baseline and after 4 weeks of intervention
Adiponectin (μg/mL)
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of adiponectin (μg/mL).
Measured: Time Frame: Baseline and after 4 weeks of intervention
Ghrelin (pg/mL)
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of ghrelin (pg/mL).
Measured: Baseline and after 4 weeks of intervention
C-reactive protein (CRP) (mg/L)
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of C-reactive protein (CRP) (mg/L).
Measured: Baseline and after 4 weeks of intervention
Interleukin-6 (IL-6) (pg/mL)
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of
Measured: Baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start15 Mar 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York - Upstate Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215533
- Sponsor's protocol ID
- 23-435
- Status last verified
- Oct 2025
- First submitted
- 28 Apr 2025
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of HIIT vs. TRE on Type 2 Diabetes Risk in Youth and Younger Adults
- ClinicalTrials.gov ID
- NCT07215533
- Acronym / sponsor ID
- 23-435
- Conditions
- Obesity and Type 2 Diabetes, Metabolic Diseases, High-intensity Interval Training, Time-restricted Eating
- Keywords
- High-intensity Interval Training, Time-restricted Eating, Obesity, Type 2 Diabetes, Youth, Young Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- State University of New York - Upstate Medical University
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As of 2015, an estimated 2 billion individuals were overweight (body mass index [BMI] ≥ 25 kg/m2), and one-third of them were obese (BMI ≥ 30 kg/m2). Obesity has become a serious health concern due to its related comorbidities, including cardiovascular disease (CVD) and type 2 diabetes (T2D). While adolescents and young adults are considered low risk for the development of CVD, individuals with obesity are still at a greater risk of CVD development than individuals without obesity. Changes to dietary and fitness habits are currently the first-line recommendations for preventing weight gain and improving cardiometabolic health in adolescents and young adults.
Caloric restriction (CR), which involves reducing caloric intake by up to 50% of normal daily calorie intake, is a common dietary intervention approach for weight management and improving cardiometabolic health in adolescents and adults with obesity.9 However, studies have shown that CR is hard to maintain, and individuals tend to regain the weight after the intervention is completed. Time-restricted eating (TRE) has been proposed as an alternative to calorie restriction (CR). TRE, a type of short-term fasting, is defined as periods of no caloric intake followed by periods of ad libitum (as much as desired) caloric intake. The fact that TRE does not intentionally limit energy intake, whereas CR does, could make it more appealing to individuals in terms of adherence, acceptability, and efficacy. TRE is an effective strategy in reducing body fat percentage and waist circumference in adolescents and adults with obesity.
Moreover, high-intensity interval training (HIIT), which involves repeating short periods of intense activity followed by low-intensity breaks, has been shown to be effective in improving cardiometabolic health (including lipids, blood pressure, and insulin sensitivity) in adults with obesity compared to other traditional exercises. In addition to its benefits on cardiometabolic health, previous studies have suggested that HIIT can be a time-efficient strategy to enhance body composition and cardiopulmonary fitness in adults with obesity.1
However, it is unknown if TRE or HIIT will produce a greater improvement in cardiometabolic health. Therefore, the goal of this study is to examine the independent effect of a 4-week TRE and HIIT intervention on cardiometabolic biomarkers in youth and young adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Behavioral: High-intensity interval trainingHIIT: 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 | Experimental | Behavioral: Time-restricted eatingParticipants 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. |
| Control Group | No intervention | –Participants randomized into the control group will be told to maintain their daily lifestyle and dietary habits for the duration of the four weeks. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval trainingAlso: HIITThe 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. | Behavioural | High-intensity interval training |
| Time-restricted eatingParticipants 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. | Behavioural | Time-restricted eating |
Primary outcome
Weight (kg)
Time frame: Baseline and after 4 weeks of intervention
Weight is measured in kilograms (kg) using a calibrated digital scale.
Height (cm)
Time frame: Baseline and after 4 weeks of intervention
Height is measured in centimeters (cm) using a wall-mounted stadiometer.
Body Mass Index (BMI)
Time frame: Baseline and after 4 weeks of intervention
Weight and height will be combined to report BMI in kg/m².
Waist Circumference and Hip Circumference
Time frame: Baseline and after 4 weeks of intervention
Waist and hip circumferences are measured while participants stand straight with their arms extended outward. A non-elastic tape measure is wrapped around the waist and hip, and measurements are taken to the nearest centimeter (cm).
Blood Lipid Profile
Time frame: Baseline and after 4 weeks of intervention
Blood lipid profile, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), and fasting glucose (FG) are measured in milligrams per deciliter (mg/dL) using the Cholestech LDX Analyzer. Blood samples are obtained via fingerstick, with the first drop wiped away and the second drop collected for analysis. Participants stand or sit comfortably during collection. After blood collection, the site is cleaned and covered with gauze and a bandage as needed. This procedure is minimally invasive and typically causes little discomfort.
Blood Pressure
Time frame: Baseline and after 4 weeks of intervention
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) are measured in millimeters of mercury (mmHg), and resting heart rate (RHR) is measured in beats per minute (bpm) using an automated blood pressure monitor. Participants sit quietly for five minutes with minimal movement prior to measurement. A cuff is placed on the right upper arm (bicep area), and the monitor initiates inflation, deflation, and reinflation cycles. Participants are instructed not to move during the measurement process. All equipment is disinfected before and after each use with antiviral, antibacterial, and antifungal disposable wipes by a researcher wearing gloves.
Carotid-Femoral Pulse Wave Velocity
Time frame: Baseline and after 4 weeks of intervention
Carotid-femoral pulse wave velocity (PWV), a preclinical marker of cardiovascular disease (CVD), is measured in meters per second (m/s) using applanation tonometry (SphygmoCor, AtCor Medical). Participants are positioned supine on a padded exam table after resting quietly for approximately five minutes. Brachial blood pressure is measured in millimeters of mercury (mmHg) using an automated cuff device. Pressure waveforms are recorded at the carotid artery (neck) and femoral artery (upper leg) using a handheld tonometer. The time delay between carotid and femoral pulse waves is used to calculate PWV, an indicator of arterial stiffness. The procedure is non-invasive and typically requires approximately five minutes to complete.
Glucose (mg/dL)
Time frame: Baseline and after 4 weeks of intervention
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of glucose (mg/dL).
Insulin (μIU/mL)
Time frame: Baseline and after 4 weeks of intervention
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of insulin (μIU/mL).
C-peptide (ng/mL)
Time frame: Baseline and after 4 weeks of intervention
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of C-peptide (ng/mL).
Total glucagon-like peptide-1 (GLP-1) (pmol/L)
Time frame: Baseline and after 4 weeks of intervention
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of total glucagon-like peptide-1 (GLP-1) (pmol/L).
Glucose-dependent insulinotropic polypeptide (GIP) (pg/mL)
Time frame: Baseline and after 4 weeks of intervention
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of glucose-dependent insulinotropic polypeptide (GIP) (pg/mL).
Leptin (ng/mL)
Time frame: Baseline and after 4 weeks of intervention
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of leptin (ng/mL).
Adiponectin (μg/mL)
Time frame: Time Frame: Baseline and after 4 weeks of intervention
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of adiponectin (μg/mL).
Ghrelin (pg/mL)
Time frame: Baseline and after 4 weeks of intervention
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of ghrelin (pg/mL).
C-reactive protein (CRP) (mg/L)
Time frame: Baseline and after 4 weeks of intervention
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of C-reactive protein (CRP) (mg/L).
Interleukin-6 (IL-6) (pg/mL)
Time frame: Baseline and after 4 weeks of intervention
After a 10- to 12-hour overnight fast, participants undergo a 2-hour oral glucose tolerance test (OGTT) at the Clinical Research Unit, SUNY Upstate Medical University. Venous blood samples are collected at -15, 0, 30, 60, 90, and 120 minutes relative to glucose ingestion. At time 0 minutes, participants consume a commercially prepared standard 75-gram glucose solution; youth participants receive 1.75 grams of glucose per kilogram of body weight, not exceeding 75 grams total. After the final blood collection at 120 minutes, participants are provided a snack and continue their study visit. Blood is collected in pre-chilled aprotinin/EDTA tubes and processed for analysis of
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joon Young Kim, PhD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Time-restricted eating in people with Obesity and Type 2 Diabetes and Metabolic Diseases, run by Syracuse University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wonhee Cho, MS, PhD Candidate (+16267270270, wcho02@syr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (kg) (time frame: Baseline and after 4 weeks of intervention). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.