Mild to moderate essential hypertension Circulatory System
Conditions
Interventions
Participants in this study are randomly assigned to one of four groups:
- Group 1: Individuals with grade 1 hypertension (systolic BP 130-150 mmHg, diastolic BP 90-95 mmHg) receive one tablet per day
Sponsors
NGN Healthcare—New Generation Nutraceuticals s.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects, of caucasian ethnicity, resident in Italy, aged 18–75 years 2. Documented diagnosis of essential hypertension for at least one year before study initiation 3. Ongoing treatment with antihypertensive medications that will not be modified during the study 4. No additional cardiological (e.g., atrial fibrillation, heart failure) or metabolic (e.g., diabetes, dyslipidaemia) comorbidities 5. Ability to understand the study procedures and to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Any autoimmune, rheumatologic or vascular disease other than essential hypertension 2. Severe hypertension (grade 3: =171/106 mmHg) 3. Diabetes mellitus 4. Irregular sleep/wake rhythm (e.g., night-shift workers within the last 3 months) 5. Total cholesterol >250 mg/dl or triglycerides >200 mg/dl 6. Cardiovascular events (myocardial infarction and/or stroke) in the past 6 months 7. Renal impairment (serum creatinine >1.5 mg/dl) or hepatic impairment (ALT/AST and/or ?-GT twice above normal values) 8. Anaemia (Hb 3 kg in the 3 months before enrolment 12. Malignant neoplasms 13. Significant neurological or psychiatric disorders, including alcohol or drug abuse 14. Concomitant therapy with: hypoglycaemic agents, laxatives, cyproheptadine, antidepressants, antiserotonergic drugs, phenothiazines, barbiturates, oral corticosteroids, or antipsychotics 15. Pregnancy or breastfeeding 16. Women of childbearing potential not using adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure measured using sphygmomanometer at baseline, 4, 8, and 12 weeks of treatment, and at the end of the 4-week follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fasting blood glucose measured using a blood glucose meter at baseline, 4, 8, and 12 weeks of treatment, and at the end of the 4-week follow-up period 2. Lipid profile (total cholesterol, LDL, HDL, triglycerides) measured using blood sample analysis at baseline, 4, 8, and 12 weeks of treatment, and at the end of the 4-week follow-up period 3. Liver function (AST and ALT) measured using blood sample analysis at baseline, 4, 8, and 12 weeks of treatment, and at the end of the 4-week follow-up period 4. Kidney function (microalbuminuria and creatinine clearance) measured using urine and blood sample analysis at baseline, 4, 8, and 12 weeks of treatment, and at the end of the 4-week follow-up period 5. Quality of life measured using the SF-12 health survey at baseline and at the end of 12 weeks of treatment | — |
Countries
Italy
Contacts
Public ContactElisabetta Schiano
Outcome results
None listed