Investigation of the Relationship Between Gray and White Matter Volumes, Walking Exercise, and Body Fat Percentage in Adults With a Body Mass Index Above 25

NCT07425093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-02-20

No results posted yet for this study

Summary

This study examines the relationship between walking exercise, body fat percentage changes, and brain gray and white matter volumes in overweight and obese adults with headache complaints. Participants with a Body Mass Index (BMI) of 25 or above will be divided into two groups: one receiving a diet program combined with a 12-week walking exercise regimen, and a control group receiving diet alone. Both groups will undergo brain MRI scans and body composition measurements at baseline and after 12 weeks. The study aims to determine whether exercise-induced reductions in body fat percentage have a measurable impact on brain structure, specifically gray and white matter volumes. Blood tests will monitor metabolic markers throughout the intervention. This research may contribute to understanding how different types of exercise affect brain health and inform the development of more effective treatments for obesity-related neurological changes.

Conditions

  • Obesity & Overweight
  • Headache
  • Sedentary Lifestyle
  • Body Fat Percentage
  • Brain Grey Matter
  • Brain White Matter

Interventions

BEHAVIORAL

Walking Exercise Program

Supervised 12-week progressive walking exercise program performed 5 days per week. Exercise intensity is determined using the Karvonen method to calculate target heart rate zones, starting at 50% and progressively increasing to 70% of maximum heart rate. Session duration begins at 20 minutes and gradually increases to 60 minutes by week 12 to support cardiovascular adaptation. Heart rate is monitored every 20 minutes during exercise using smartphone applications with integrated pulse measurement capabilities. Participants receive individualized heart rate targets and step count goals based on their baseline fitness level and age.

BEHAVIORAL

Dietary Intervention

Individualized calorie-restricted diet program calculated using the Mifflin-St. Jeor equation based on participants' current weight, height, age, and physical activity level. Diet creates a 500-750 kcal/day energy deficit targeting 0.5-1 kg weekly weight loss with a goal of 5% body weight reduction over 12 weeks. Macronutrient distribution: 50-60% carbohydrates, 15-20% protein, 25-30% fat, following Turkish Ministry of Health dietary guidelines. Participants attend 6 biweekly individual nutrition counseling sessions with a registered dietitian over the 12-week intervention period to review progress, adjust meal plans, and provide ongoing support and education.

DIAGNOSTIC_TEST

Brain MRI Morphometry

Brain magnetic resonance imaging performed at baseline and 12 weeks using 1.5 Tesla Siemens Magnetom Avanto scanner with standard head coil. Imaging protocol includes: (1) T2-weighted axial images using 3D Spoiled Gradient (SPGR) sequence (TR=800ms, TE=26ms, FOV=230mm, matrix=192x256, slice thickness=5mm) for volumetric analysis; (2) T1-weighted axial images (FOV=420mm, FOV Phase=81.3%, slice thickness=6mm, TR=170ms, TE=2.38ms). Images will be analyzed for gray matter and white matter volumes using standardized morphometric techniques. The 12-week follow-up MRI is funded by the research team.

DIAGNOSTIC_TEST

Body Composition Analysis

Body composition measurements performed at baseline and biweekly throughout the 12-week intervention (6 total assessments) using InBody 370 bioelectrical impedance analysis device. Measurements are standardized with participants wearing light clothing, barefoot, in a fasted state (minimum 2 hours), and 30 minutes post-void to ensure accuracy. Parameters assessed include body fat percentage, skeletal muscle mass, total body water, and segmental body composition. A fixed 0.50 kg clothing allowance is applied to all measurements for consistency.

DIAGNOSTIC_TEST

Blood Biomarker Analysis

Fasting venous blood samples (approximately 5 mL) collected at baseline and 12 weeks after minimum 12-hour fast, standardized to 09:00 AM collection time to minimize circadian variation. Metabolic parameters analyzed include: fasting glucose, lipid profile (total cholesterol, LDL, HDL, triglycerides), liver enzymes (ALT, AST, GGT), thyroid function (T3, T4, TSH), vitamin B12, complete blood count (hemogram), and HbA1c. Blood samples are analyzed using standardized laboratory equipment: Beckman Coulter for glucose and lipids, Siemens Advia Centaur XP for hormones, Sysmex XN-1000 for hematology, and Premier Hb9210 for HbA1c.

Sponsors & Collaborators

  • Amasya University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-03-01
Completion
2024-03-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07425093 on ClinicalTrials.gov