Obesity & Overweight, Headache, Sedentary Lifestyle, Body Fat Percentage, Brain Grey Matter, Brain White Matter
Conditions
Keywords
obesity, brain grey matter, brain white matter, mri brain, weight loss, diet intervention, body mass index, physical activity, aerobic exercise
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.
Detailed description
Background: Obesity has become a major public health concern over the past 40 years, with increasing evidence linking elevated BMI to numerous physical and mental health problems. Neuroimaging studies demonstrate that obesity negatively affects brain function and structure, particularly within the fronto-mesolimbic circuit. Structural MRI studies have revealed associations between obesity and reduced gray/white matter volumes, altered cortical morphometry, and impaired white matter integrity. Research highlights obesity's impact on cognitive functions including decision-making, inhibition control, learning/memory, and attention. Study Design: This is a 12-week prospective experimental study with a control group design. The study will recruit 22 adults (11 per group) with BMI ≥25 who present with headache complaints to the neurosurgery department between January-March 2024. Inclusion Criteria: Adults aged 19-65 years with headache complaints BMI ≥25 kg/m² Brain MRI performed between 01.01.2024-01.03.2024 Baseline blood tests completed (fasting glucose, lipid profile, liver enzymes, thyroid function, vitamin B12, hemogram, HbA1c) Scheduled for routine 6-month follow-up blood work Willing to undergo follow-up brain MRI at 12 weeks (funded by researchers) Able to attend 6 biweekly nutrition counseling sessions over 12 weeks Able to attend 6 biweekly body composition measurements No diagnosed chronic conditions (hypertension, diabetes) Proficient with smartphone heart rate and step counter applications Exclusion Criteria: Chronic diseases (hypertension, diabetes) Physical disabilities Use of antidepressant medications Regular exercise practitioners History of cerebrovascular disease Epilepsy diagnosis Multiple sclerosis or Alzheimer's disease Conditions affecting brain ventricular volume (e.g., hydrocephalus) Pregnancy or breastfeeding Intervention: Exercise Protocol (Experimental Group): Exercise intensity will be determined using the Karvonen method to establish target heart rate. Walking exercise will be prescribed 5 days per week, with progressive intensity increases from 50% to 70% maximum heart rate over 12 weeks. Session duration will gradually increase from 20 minutes initially to 60 minutes by week 12 to support adaptation and achieve maximum heart rate targets. Heart rate will be monitored every 20 minutes during exercise using smartphone applications. Diet Protocol (Both Groups): Individual energy needs will be calculated using Mifflin-St. Jeor equations based on current weight. Physical activity level (PAL) will be determined, and total energy expenditure calculated. Diet prescriptions will create a 500-750 kcal/day deficit targeting 0.5-1 kg weekly weight loss, with a goal of 5% weight reduction over 12 weeks. Macronutrient distribution will be 50-60% carbohydrates, 15-20% protein, and 25-30% fat. Measurements: Baseline and 12-Week Assessments: Sociodemographic Data: Personal interview form Anthropometrics: Height measured with SECA 216 stadiometer; BMI calculated Body Composition: InBody 370 bioelectrical impedance analysis under standardized conditions (light clothing, barefoot, fasted ≥2 hours, post-void 30 minutes) Blood Samples: Fasting (12 hours) venous blood collected at 09:00 AM to minimize circadian variation. Analysis includes fasting glucose, lipid profile, liver enzymes (ALT, AST, GGT), thyroid function (T3, T4, TSH), vitamin B12, complete blood count, and HbA1c Brain MRI: Performed using 1.5T Siemens Magnetom Avanto scanner with standard head coil. T2-weighted axial images using 3D SPGR sequence (TR=800ms, TE=26ms, FOV=230mm, resolution=192x256, slice thickness=5mm). T1-weighted axial images (FOV=420mm, FOV Phase=81.3%, slice thickness=6mm, TR=170ms, TE=2.38ms)
Interventions
BEHAVIORALWalking 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.
BEHAVIORALDietary 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_TESTBrain 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_TESTBody 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_TESTBlood 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
Amasya University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 19-65 years 2. Body Mass Index (BMI) ≥25 kg/m² 3. Presented to the neurosurgery department with headache complaints between January 1, 2024 and March 1, 2024 4. Underwent brain magnetic resonance imaging (MRI) between January 1, 2024 and March 1, 2024 5. 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) 6. Scheduled for routine 6-month follow-up blood work based on initial test results 7. Willing to undergo follow-up brain MRI at 12 weeks (costs covered by research team) 8. Willing and able to attend 6 biweekly nutrition counseling sessions over 12 weeks with the study dietitian 9. Willing and able to attend 6 biweekly body composition measurement appointments over 12 weeks 10. No diagnosed chronic conditions including hypertension or diabetes 11. Owns a smartphone and is proficient in using smartphone applications for heart rate monitoring and step counting
Exclusion criteria
1. Did not present to the neurosurgery department with headache complaints between January 1, 2024 and March 1, 2024 2. Did not undergo brain MRI between January 1, 2024 and March 1, 2024 3. 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 4. BMI \<25 kg/m² 5. Unable or unwilling to attend 6 biweekly nutrition counseling sessions over 12 weeks 6. Unable or unwilling to attend 6 biweekly body composition measurement appointments over 12 weeks 7. Diagnosed chronic diseases including hypertension or diabetes 8. Unable to use smartphone applications for heart rate monitoring and step counting, or does not own a smartphone 9. Physical disabilities that would prevent walking exercise 10. Current use of antidepressant medications 11. Currently engaged in regular exercise programs 12. History of cerebrovascular disease (stroke, transient ischemic attack) 13. Diagnosis of epilepsy 14. Diagnosis of Multiple Sclerosis or Alzheimer's disease 15. Conditions affecting brain ventricular volume (e.g., hydrocephalus) 16. Pregnancy 17. Currently breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brain Gray Matter Volume | Baseline and 12 weeks | 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). |
| Change in Brain White Matter Volume | Baseline and 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Fat Percentage | Baseline, weeks 2, 4, 6, 8, 10, and 12 (7 total assessments) | Change in body fat percentage measured by bioelectrical impedance analysis using InBody 370 device. Measurements performed under standardized conditions (fasted ≥2 hours, post-void 30 minutes, light clothing, barefoot). Body fat percentage expressed as percentage of total body weight. Change calculated as: (12-week percentage) - (baseline percentage). |
| Change in Body Weight | Baseline, weeks 2, 4, 6, 8, 10, and 12 (7 total assessments) | Change in body weight measured in kilograms using InBody 370 bioelectrical impedance analysis device with standardized 0.50 kg clothing allowance. Change calculated as: (12-week weight) - (baseline weight). Percent weight change also calculated as: \[(12-week weight - baseline weight) / baseline weight\] × 100. |
| Change in Body Mass Index (BMI) | Baseline and 12 weeks | Change in Body Mass Index calculated as weight (kg) divided by height squared (m²). Height measured using SECA 216 stadiometer at baseline. BMI expressed in kg/m². Change calculated as: (12-week BMI) - (baseline BMI). |
| Change in Fasting Blood Glucose | Baseline and 12 weeks | Change in fasting blood glucose concentration measured in mg/dL from venous blood samples collected after minimum 12-hour fast at standardized time (09:00 AM). Analyzed using Beckman Coulter automated analyzer. Change calculated as: (12-week glucose) - (baseline glucose). |
| Change in Lipid Profile | Baseline and 12 weeks | Change in lipid panel including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, all measured in mg/dL from fasting venous blood samples. Analyzed using Beckman Coulter automated analyzer. Changes calculated as: (12-week values) - (baseline values) for each lipid parameter. |
| Change in Liver Enzymes | Baseline and 12 weeks | Change in liver function markers including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT), measured in U/L from fasting venous blood samples. Analyzed using Beckman Coulter automated analyzer. Changes calculated as: (12-week values) - (baseline values) for each enzyme. |
| Change in Hemoglobin A1c (HbA1c) | Baseline and 12 weeks | Change in glycated hemoglobin (HbA1c) measured as percentage of total hemoglobin from venous blood samples. Analyzed using Premier Hb9210 automated analyzer. Change calculated as: (12-week HbA1c) - (baseline HbA1c). |
Countries
Turkey (Türkiye)
Outcome results
None listed