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 | Completed

• 1 other identifier: 050.04-190521
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

obesity; brain grey matter; brain white matter; mri brain; weight loss; diet intervention; body mass index; physical activity; aerobic exercise

Outcome Measures

Primary Outcomes (2)

• Change in Brain Gray Matter Volume

  Change in total cerebral gray matter volume measured by structural MRI morphometry using 1.5T Siemens Magnetom Avanto scanner. Volumetric analysis performed using T2-weighted 3D SPGR sequences (TR=800ms, TE=26ms, slice thickness=5mm) and T1-weighted axial images. Gray matter volume quantified in cubic centimeters (cm³) or milliliters (mL). Change calculated as: (12-week volume) - (baseline volume).

  Baseline and 12 weeks

• Change in Brain White Matter Volume

  Change in total cerebral white matter volume measured by structural MRI morphometry using 1.5T Siemens Magnetom Avanto scanner. Volumetric analysis performed using T2-weighted 3D SPGR sequences (TR=800ms, TE=26ms, slice thickness=5mm) and T1-weighted axial images. White matter volume quantified in cubic centimeters (cm³) or milliliters (mL). Change calculated as: (12-week volume) - (baseline volume).

  Baseline and 12 weeks

Secondary Outcomes (7)

• Change in Body Fat Percentage

  Baseline, weeks 2, 4, 6, 8, 10, and 12 (7 total assessments)

• Change in Body Weight

  Baseline, weeks 2, 4, 6, 8, 10, and 12 (7 total assessments)

• Change in Body Mass Index (BMI)

  Baseline and 12 weeks

• Change in Fasting Blood Glucose

  Baseline and 12 weeks

• Change in Lipid Profile

  Baseline and 12 weeks

Other Outcomes (5)

• Correlation Between Body Fat Percentage Change and Gray Matter Volume Change

  12 weeks (correlation of changes from baseline to week 12)

• Correlation Between Body Fat Percentage Change and White Matter Volume Change

  12 weeks (correlation of changes from baseline to week 12)

• Change in Thyroid Function Markers

  Baseline and 12 weeks

Study Arms (2)

Experimental: Walking Exercise + Diet

EXPERIMENTAL

Participants in this arm will receive a personalized diet program combined with a 12-week supervised walking exercise intervention. Exercise intensity will be determined using the Karvonen method to establish target heart rate, with progressive increases from 50% to 70% maximum heart rate. Walking will be performed 5 days per week, with duration gradually increasing from 20 minutes to 60 minutes over 12 weeks. Heart rate will be monitored every 20 minutes using smartphone applications. Diet will create a 500-750 kcal/day deficit with macronutrient distribution of 50-60% carbohydrates, 15-20% protein, and 25-30% fat. Participants will attend 6 biweekly nutrition counseling sessions and 6 biweekly body composition measurements over the 12-week period.

Behavioral: Walking Exercise Program; Behavioral: Dietary Intervention; Diagnostic Test: Brain MRI Morphometry; Diagnostic Test: Body Composition Analysis; Diagnostic Test: Blood Biomarker Analysis

Active Comparator: Diet Only

ACTIVE COMPARATOR

Participants in this arm will receive the same personalized diet program as the experimental group but without the walking exercise component. Diet will create a 500-750 kcal/day deficit with macronutrient distribution of 50-60% carbohydrates, 15-20% protein, and 25-30% fat. Participants will attend 6 biweekly nutrition counseling sessions and 6 biweekly body composition measurements over the 12-week period. This group serves as an active control to isolate the specific effects of exercise on brain structure beyond those achieved through dietary weight loss alone.

Behavioral: Dietary Intervention; Diagnostic Test: Brain MRI Morphometry; Diagnostic Test: Body Composition Analysis; Diagnostic Test: Blood Biomarker Analysis

Interventions

Walking Exercise Program BEHAVIORAL

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.

Experimental: Walking Exercise + Diet

Dietary Intervention BEHAVIORAL

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.

Active Comparator: Diet Only; Experimental: Walking Exercise + Diet

Brain MRI Morphometry DIAGNOSTIC_TEST

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.

Active Comparator: Diet Only; Experimental: Walking Exercise + Diet

Body Composition Analysis DIAGNOSTIC_TEST

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.

Active Comparator: Diet Only; Experimental: Walking Exercise + Diet

Blood Biomarker Analysis DIAGNOSTIC_TEST

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.

Active Comparator: Diet Only; Experimental: Walking Exercise + Diet

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19-65 years
• Body Mass Index (BMI) ≥25 kg/m²
• Presented to the neurosurgery department with headache complaints between January 1, 2024 and March 1, 2024
• Underwent brain magnetic resonance imaging (MRI) between January 1, 2024 and March 1, 2024
• Completed baseline blood tests between January 1, 2024 and March 1, 2024, including:
• Fasting blood glucose
• Lipid profile (total cholesterol, LDL, HDL, triglycerides)
• Liver enzymes (ALT, AST, GGT)
• Thyroid function tests (T3, T4, TSH)
• Vitamin B12
• Complete blood count (hemogram)
• Hemoglobin A1c (HbA1c)
• Scheduled for routine 6-month follow-up blood work based on initial test results
• Willing to undergo follow-up brain MRI at 12 weeks (costs covered by research team)
• Willing and able to attend 6 biweekly nutrition counseling sessions over 12 weeks with the study dietitian

You may not qualify if:

• Did not present to the neurosurgery department with headache complaints between January 1, 2024 and March 1, 2024
• Did not undergo brain MRI between January 1, 2024 and March 1, 2024
• Did not complete required baseline blood tests (fasting glucose, lipid profile, liver enzymes, thyroid function, vitamin B12, hemogram, HbA1c) between January 1, 2024 and March 1, 2024
• BMI \<25 kg/m²
• Unable or unwilling to attend 6 biweekly nutrition counseling sessions over 12 weeks
• Unable or unwilling to attend 6 biweekly body composition measurement appointments over 12 weeks
• Diagnosed chronic diseases including hypertension or diabetes
• Unable to use smartphone applications for heart rate monitoring and step counting, or does not own a smartphone
• Physical disabilities that would prevent walking exercise
• Current use of antidepressant medications
• Currently engaged in regular exercise programs
• History of cerebrovascular disease (stroke, transient ischemic attack)
• Diagnosis of epilepsy
• Diagnosis of Multiple Sclerosis or Alzheimer's disease
• Conditions affecting brain ventricular volume (e.g., hydrocephalus)

Sponsors & Collaborators

• Amasya University: lead

Study Sites (2)

Amasya Sabuncuoglu Serefeddin Training and Research Hospital

Amasya, 05100, Turkey (Türkiye)

Location

Kolmed Hospital

Amasya, 05100, Turkey (Türkiye)

Location

Related Publications (2)

• Kullmann S, Callaghan MF, Heni M, Weiskopf N, Scheffler K, Haring HU, Fritsche A, Veit R, Preissl H. Specific white matter tissue microstructure changes associated with obesity. Neuroimage. 2016 Jan 15;125:36-44. doi: 10.1016/j.neuroimage.2015.10.006. Epub 2015 Oct 13.

  PMID: 26458514 BACKGROUND

• Jaacks LM, Vandevijvere S, Pan A, McGowan CJ, Wallace C, Imamura F, Mozaffarian D, Swinburn B, Ezzati M. The obesity transition: stages of the global epidemic. Lancet Diabetes Endocrinol. 2019 Mar;7(3):231-240. doi: 10.1016/S2213-8587(19)30026-9. Epub 2019 Jan 28.

  PMID: 30704950 BACKGROUND

Related Links

• Official website of Amasya University, host institution for the ethics committee that approved this study (approval number: 2024/42)

MeSH Terms

Conditions

Obesity; Overweight; Headache; Sedentary Behavior; Weight Loss; Motor Activity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, care providers, and investigators are aware of group assignments. However, MRI morphometric analyses will be performed by radiologists who may be blinded to group allocation to reduce measurement bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel groups will be followed for 12 weeks. The experimental group will receive a walking exercise program plus diet intervention, while the control group will receive diet intervention only. Both groups will undergo identical assessments at baseline and 12 weeks, including brain MRI, body composition analysis, and blood tests.

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: February 20, 2026
• Study Start: January 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)