Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07425093
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT07425093
Study Brief:
Protocol Section:
NCT07425093