Obesity & OverweightNCT07425093
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
A study testing Walking Exercise Program, Dietary Intervention and Brain MRI Morphometry in people with Obesity & Overweight and Headache, run by Amasya University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Obesity & Overweight, Headache, Sedentary Lifestyle
- What is being tested?
- Walking Exercise Program, Dietary Intervention and Brain MRI Morphometry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
- Willing and able to attend 6 biweekly body composition measurement appointments over 12 weeks
- No diagnosed chronic conditions including hypertension or diabetes
- Owns a smartphone and is proficient in using smartphone applications for heart rate monitoring and step counting
Who cannot join
- 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
Show all 17Show fewer
- 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)
- Pregnancy
- Currently breastfeeding
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Amasya Sabuncuoglu Serefeddin Training and Research Hospital
Amasya, 05100
Kolmed Hospital
Amasya, 05100
About this study
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.
Read the 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)
- Conditions
- Obesity & Overweight, Headache, Sedentary Lifestyle, Body Fat Percentage, Brain Grey Matter, Brain White Matter
- Being tested
- Walking Exercise Program, Dietary Intervention, Brain MRI Morphometry, Body Composition Analysis, Blood Biomarker Analysis
- Keywords
- obesity, brain grey matter, brain white matter, mri brain, weight loss, diet intervention, body mass index, physical activity, aerobic exercise
- Medical subject headings
- Obesity, Overweight, Headache, Sedentary Behavior, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking Exercise ProgramBehavioural
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.
Dietary InterventionBehavioural
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.
Brain MRI MorphometryDiagnostic 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.
Body Composition AnalysisDiagnostic 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.
Blood Biomarker AnalysisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Dietary Intervention; Diagnostic Test: Brain MRI Morphometry; Diagnostic Test: Body Composition Analysis; Diagnostic Test: Blood Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline and 12 weeks
Secondary outcomes (7)
Change in Body Fat Percentage
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).
Measured: Baseline, weeks 2, 4, 6, 8, 10, and 12 (7 total assessments)
Change in Body Weight
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.
Measured: Baseline, weeks 2, 4, 6, 8, 10, and 12 (7 total assessments)
Change in Body Mass Index (BMI)
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).
Measured: Baseline and 12 weeks
Change in Fasting Blood Glucose
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).
Measured: Baseline and 12 weeks
Change in Lipid Profile
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.
Measured: Baseline and 12 weeks
Change in Liver Enzymes
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.
Measured: Baseline and 12 weeks
Change in Hemoglobin A1c (HbA1c)
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).
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jan 2024
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425093
- Sponsor's protocol ID
- 050.04-190521
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26458514Jaacks 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.
PubMed 30704950
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07425093
- Acronym / sponsor ID
- 050.04-190521
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Walking Exercise + Diet | Experimental | Behavioral: Walking Exercise Program, Behavioral: Dietary Intervention, Diagnostic Test: Brain MRI Morphometry, Diagnostic Test: Body Composition Analysis, Diagnostic Test: Blood Biomarker AnalysisParticipants 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. |
| Active Comparator: Diet Only | Active comparator | Behavioral: Dietary Intervention, Diagnostic Test: Brain MRI Morphometry, Diagnostic Test: Body Composition Analysis, Diagnostic Test: Blood Biomarker AnalysisParticipants 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking Exercise ProgramSupervised 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. | Behavioural | Experimental: Walking Exercise + Diet |
| Dietary InterventionIndividualized 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. | Behavioural | Active Comparator: Diet Only, Experimental: Walking Exercise + Diet |
| Brain MRI MorphometryBrain 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 | Active Comparator: Diet Only, Experimental: Walking Exercise + Diet |
| Body Composition AnalysisBody 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 | Active Comparator: Diet Only, Experimental: Walking Exercise + Diet |
| Blood Biomarker AnalysisFasting 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. | Diagnostic test | Active Comparator: Diet Only, Experimental: Walking Exercise + Diet |
Primary outcome
Change in Brain Gray Matter Volume
Time frame: 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
Time frame: 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).
7 secondary outcomes
Change in Body Fat Percentage
Time frame: Baseline, weeks 2, 4, 6, 8, 10, and 12 (7 total assessments)
Change in Body Weight
Time frame: Baseline, weeks 2, 4, 6, 8, 10, and 12 (7 total assessments)
Change in Body Mass Index (BMI)
Time frame: Baseline and 12 weeks
Change in Fasting Blood Glucose
Time frame: Baseline and 12 weeks
Change in Lipid Profile
Time frame: Baseline and 12 weeks
Change in Liver Enzymes
Time frame: Baseline and 12 weeks
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 26458514Kullmann 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.
- Background: PubMed 30704950Jaacks 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.
- Official website of Amasya University, host institution for the ethics committee that approved this study (approval number: 2024/42)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Exercise Program, Dietary Intervention and Brain MRI Morphometry in people with Obesity & Overweight and Headache, run by Amasya University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain Gray Matter Volume (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07425093, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.