Clinical trial NCT06973980: HIIT in Sedentary Obese Adults: Effects on Metabolic Risk, Body Composition, and FABP4
Official title: The Effect of High-Intensity Interval Training on Cardiometabolic Risk Factors, Body Composition, and Plasma FABP4 Levels in Sedentary Obese Adults.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High-Intensity Interval Training
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is aimed to investigate the responses of Fatty Acid Binding Protein 4 (FABP4), which has been discovered as a novel biomarker of obesity and metabolic diseases, to regular exercise training.

The aim of this study is to investigate the effects of high-intensity interval training (HIIT) on cardiometabolic risk factors, body composition, and plasma FABP4 levels in sedentary obese adults.

Detailed description: Fatty acid binding proteins are intracellular proteins involved in the transport of fatty acids and are particularly associated with lipolytic activity. These proteins constitute a group of molecules that regulate intracellular lipid responses and are linked to metabolic and inflammatory pathways.

Studies have shown that FABP4 is associated with hypertension, insulin resistance, obesity, and stroke.

Inhibition of FABP4 synthesis has emerged as a promising strategy for the treatment of obesity-related conditions, particularly insulin resistance and diabetes, and it is emphasized that exercise models to suppress FABP4 should be further investigated.

The aim of this study is to investigate the effects of high-intensity interval training (HIIT) on cardiometabolic risk factors, body composition, and plasma FABP4 levels in sedentary obese adults.

Hypotheses:

H01: HIIT has no effect on cardiometabolic risk factors in sedentary obese adults.

H02: HIIT has no effect on body composition in sedentary obese adults. H03: HIIT has no effect on plasma FABP4 levels in sedentary obese adults.

Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 35 years,
* BMI between 30 and 35 kg/m²,
* Waist circumference of 90-100 cm for women, 105-110 cm for men,
* Sedentary lifestyle (\<600 MET-min/week),
* Referred by a physician (with a statement confirming no contraindication to exercise)."

Exclusion Criteria:

* BMI \> 35,
* Pregnancy,
* Cardiovascular Diseases: Individuals with serious cardiovascular issues, such as uncontrolled hypertension, heart failure, coronary artery disease, or a heart attack within the last 6 months, which could pose a risk during exercise.
* Respiratory Diseases: Individuals with chronic respiratory conditions, such as uncontrolled or severe asthma or COPD, who cannot tolerate exercise due to their condition.
* Neurological Disorders: Individuals with neurological issues that limit exercise capacity, such as Parkinson's disease, stroke, or multiple sclerosis.
* Musculoskeletal Issues: Individuals with chronic musculoskeletal problems, particularly knee or hip osteoarthritis, that may increase the risk of pain or injury during exercise.
* Metabolic or Endocrine Disorders: Individuals with uncontrolled metabolic issues, such as diabetes or thyroid disorders, that could cause blood sugar or hormonal fluctuations during exercise.
* Acute Infections or Illness: Individuals with acute infections, fever, or recently undergone surgical procedures.
* Any health condition that may prevent participation in exercise."

Primary outcomes:
measure: Fatty acid-bling protein 4
timeFrame: Baseline, week 6 and week 12
measure: Complete Blood Count
timeFrame: Baseline, week 6 and week 12
measure: Hemoglobin A1c (HbA1c)
timeFrame: Baseline, week 6 and week 12
measure: Hematocrit (HCT)
timeFrame: Baseline, week 6 and week 12
measure: Low-Density Lipoprotein
timeFrame: Baseline, week 6 and week 12
measure: High-Density Lipoprotein
timeFrame: Baseline, week 6 and week 12
measure: Triglycerides
timeFrame: Baseline, week 6 and week 12
measure: Fasting Blood Glucose (FBG)
timeFrame: Baseline, week 6 and week 12
measure: Total Cholesterol
timeFrame: Baseline, week 6 and week 12
Secondary outcomes:
measure: Physical Activity Level Assessment
timeFrame: Baseline, week 6 and week 12
measure: Physical activity level
timeFrame: Baseline, week 6 and week 12
measure: Assessment of Aerobic Capacity and Exercise Intensity - used to measure an individual's maximal oxygen uptake (VO2max) and determine the intensity of exercise
timeFrame: Baseline, week 6 and week 12
measure: Anthropometric Measurements
timeFrame: Baseline, week 6 and week 12
measure: Antropometric Measurement
timeFrame: Baseline, week 6 and week 12
measure: Antropometric Measurement
timeFrame: Baseline, week 6 and week 12
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
affiliation: Eastern Meditterean university
name: YAŞAM DİREL, MSc
role: PRINCIPAL_INVESTIGATOR
References: