Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT07215533
Status:
RECRUITING
Last Update Posted:
2025-10-10
First Post:
2025-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of HIIT vs. TRE on Type 2 Diabetes Risk
Sponsor:
Syracuse University
Organization:
Study Overview
Official Title:
Differential Effects of HIIT vs. TRE on Type 2 Diabetes Risk in Youth and Younger Adults
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: