Investigation of the Relationship Between Gray and White Matter Volumes, Walking Exercise, and Bo… (NCT07425093) | Clinical Trial Compass
CompletedNot Applicable
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
Turkey (Türkiye)22 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
Age range
19 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Willing and able to attend 6 biweekly nutrition counseling sessions over 12 weeks with the study dietitian
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