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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Amasya University
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Change in Brain Gray Matter Volume
Study Overview
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:
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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)
- •Currently breastfeeding
Arms & Interventions
Experimental: Walking Exercise + Diet
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.
Intervention: Blood Biomarker Analysis (Diagnostic Test)
Experimental: Walking Exercise + Diet
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.
Intervention: Brain MRI Morphometry (Diagnostic Test)
Experimental: Walking Exercise + Diet
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.
Intervention: Walking Exercise Program (Behavioral)
Experimental: Walking Exercise + Diet
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.
Intervention: Dietary Intervention (Behavioral)
Experimental: Walking Exercise + Diet
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.
Intervention: Body Composition Analysis (Diagnostic Test)
Active Comparator: Diet Only
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.
Intervention: Dietary Intervention (Behavioral)
Active Comparator: Diet Only
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.
Intervention: Brain MRI Morphometry (Diagnostic Test)
Active Comparator: Diet Only
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.
Intervention: Body Composition Analysis (Diagnostic Test)
Active Comparator: Diet Only
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.
Intervention: Blood Biomarker Analysis (Diagnostic Test)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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)
- Change in Liver Enzymes(Baseline and 12 weeks)
- Change in Hemoglobin A1c (HbA1c)(Baseline and 12 weeks)