HIIT in Sedentary Obese Adults: Effects on Metabolic Risk, Body Composition, and FABP4

NCT06973980 | Recruiting

• 1 other identifier: YDIREL
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Intensity Interval Training

Outcome Measures

Primary Outcomes (9)

• Fatty acid-bling protein 4

  The Human FABP4 (Fatty Acid Binding Protein 4, Adipocyte) ELISA Kit/96T/Feiyuebio will be used to evaluate fatty acid-binding proteins in the biological samples collected from the participants.

  Baseline, week 6 and week 12

• Complete Blood Count

  used to evaluate overall health and detect a wide range of disorders, including anemia, infection, and many other diseases.

  Baseline, week 6 and week 12

• Hemoglobin A1c (HbA1c)

  used to measure the average blood glucose levels over the past 2 to 3 months; commonly used in the diagnosis and management of diabetes.

  Baseline, week 6 and week 12

• Hematocrit (HCT)

  sed to measure the proportion of red blood cells in the blood; helps evaluate conditions such as anemia, dehydration, and other blood disorders.

  Baseline, week 6 and week 12

• Low-Density Lipoprotein

  used to measure the level of "bad" cholesterol in the blood; high levels are associated with an increased risk of cardiovascular disease.

  Baseline, week 6 and week 12

• High-Density Lipoprotein

  Used to quantify the concentration of high-density lipoprotein (HDL) cholesterol in the bloodstream; elevated levels of HDL are inversely correlated with the risk of cardiovascular diseases, suggesting a protective effect on heart health.

  Baseline, week 6 and week 12

• Triglycerides

  used to measure the concentration of triglycerides (a type of fat) in the blood; elevated levels are associated with an increased risk of cardiovascular disease, metabolic syndrome, and other health conditions.

  Baseline, week 6 and week 12

• Fasting Blood Glucose (FBG)

  used to measure the concentration of glucose in the blood after an overnight fast; elevated levels may indicate impaired glucose metabolism or diabetes mellitus.

  Baseline, week 6 and week 12

• Total Cholesterol

  used to measure the overall concentration of cholesterol in the blood, including low-density lipoprotein (LDL), high-density lipoprotein (HDL), and very-low-density lipoprotein (VLDL); elevated levels are associated with an increased risk of cardiovascular diseases.

  Baseline, week 6 and week 12

Secondary Outcomes (6)

• Physical Activity Level Assessment

  Baseline, week 6 and week 12

• Physical activity level

  Baseline, week 6 and week 12

• Assessment of Aerobic Capacity and Exercise Intensity - used to measure an individual's maximal oxygen uptake (VO2max) and determine the intensity of exercise

  Baseline, week 6 and week 12

• Anthropometric Measurements

  Baseline, week 6 and week 12

• Antropometric Measurement

  Baseline, week 6 and week 12

Study Arms (2)

Exercise Group

EXPERIMENTAL

High-Intensity Interval Training (HIIT) 1-minute interval, 1-minute active recovery 5-minute warm-up, 3-minute cool-down at 60% of peak heart rate. Weeks 1-2: Intensity at 85% of peak heart rate during work, active recovery at 60% of peak heart rate, 4 sets of 1-minute work. Weeks 2-7: Intensity at 90% of peak heart rate during work, active recovery at 60% of peak heart rate, 6 sets of 1-minute work. Weeks 8-12: Intensity at 90% of peak heart rate during work, active recovery at 60% of peak heart rate, 8 sets of 1-minute work.

Other: Exercise

Control Group

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

Exercise OTHER

The exercises will be applied only to the intervention group for 12 weeks and will be progressively intensified every 4 weeks.

Exercise Group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)."

You may not qualify if:

• 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."

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99450, Cyprus

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• YAŞAM DİREL, MSc

  Eastern Meditterean university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YAŞAM DİREL, MSc

CONTACT

0090 392 6303939; yasamdirel001@gmail.com

Mehtap MALKOÇ, Professor.

CONTACT

0090 392 6303939; mehtap.malkoc@emu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 15, 2025
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)