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

NCT ID: NCT06973980

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-09-01

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.

Conditions

High-Intensity Interval Training

Study Design

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

Study Groups

Exercise Group

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

Control Group

No intervention will be applied to the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

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

Intervention Type: OTHER

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."

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YAŞAM DİREL, MSc

Role: PRINCIPAL_INVESTIGATOR

Eastern Meditterean university

Locations

Eastern Mediterranean University

Famagusta, , Cyprus

Site Status: RECRUITING

Countries

Cyprus

Central Contacts

YAŞAM DİREL, MSc

Role: CONTACT

yasamdirel001@gmail.com

0090 392 6303939

Mehtap MALKOÇ, Professor.

Role: CONTACT

mehtap.malkoc@emu.edu.tr

0090 392 6303939

Facility Contacts

Yaşam Direl, MSc

Role: primary

yasamdirel001@gmail.com

0090 392 6303939

Mehtap Malkoç, Proffesor

Role: backup

mehtap.malkoc@emu.edu.tr

0090 392 6303939

Other Identifiers

YDIREL

Identifier Type: -

Identifier Source: org_study_id