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:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT05669404
Eligibility Criteria:
Inclusion Criteria:
1. High normal BP (office systolic BP: 130-139 mmHg and/or office diastolic BP: 85-89 mmHg) or grade 1 hypertension (office systolic BP: 140-159 mmHg and/or office diastolic BP: 90-99 mmHg) and low-moderate 10-year cardiovascular disease risk.
2. Willingness to participate in a dietary intervention to control BP and to attend individual sessions.
3. Signed informed consent form for participation.
Exclusion Criteria:
1. Current use of anti-hypertensive medications.
2. Current use of any other medications or agents affecting BP levels (e.g., nonsteroidal anti-inflammatory drugs).
3. Use of food supplements accompanied by a refusal to discontinue them.
4. Participation in a clinical study involving a drug or device within 3 months of screening.
5. Active weight loss or participation in a weight loss treatment program within 3 months of screening.
6. Secondary hypertension.
7. Atomic history of cardiovascular disease (e.g. acute myocardial infarction, stroke, heart failure).
8. Diabetes Mellitus (Type 1 \& 2).
9. Chronic kidney disease, defined as an estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73m2.
10. Liver disease (e.g., hepatitis, cirrhosis).
11. Lung disease (e.g., chronic obstructive pulmonary disease).
12. Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
13. Celiac disease.
14. Active malignancy or cancer therapy.
15. Current major psychiatric disorder or current drug abuse.
16. Body Mass Index \>40 kg/m2.
17. Current alcohol consumption \>14 drinks per week.
18. Current or planned pregnancy before the end of the study, or breast-feeding.
19. Any concomitant conditions that in the opinion of the investigator interfere with the diet or other situations requiring specific nutritional management.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05669404
Study Brief:
Protocol Section:
NCT05669404