Effects of HIIT vs. TRE on Type 2 Diabetes Risk

NCT ID: NCT07215533

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2025-12-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High-intensity interval training

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Time-restricted eating

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

HIIT

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: collaborator

Syracuse University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Syracuse University

Syracuse, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Wonhee Cho, MS, PhD Candidate

Role: CONTACT

wcho02@syr.edu

+16267270270

Joon Young Kim, PhD, PhD

Role: CONTACT

jkim291@syr.edu

Facility Contacts

Joon Young Kim, PhD

Role: primary

jkim291@syr.edu

315-443-2115

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

23-435

Identifier Type: -

Identifier Source: org_study_id