Hypertension and arterial stiffness Circulatory System Essential (primary) hypertension
Conditions
Interventions
After a 7-day run-in period, participants were randomly assigned to consume a hot beverage containing 150 mg tea polyphenols (equivalent to 129 mg flavonoids) or placebo twice a day for 8 days in a do
for 100 ml of product: fats 27 g, carbohydrates 12.6 g, proteins 2.1 g
energy value 302 kcal) approximately 30 minutes after consuming the test product. Patients did not present any pain during the measures.
Composition of the test products (black tea) (
Sponsors
Unilever Food and Health Research Institute (UFHRI) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Never-treated essential hypertensive (EH) patients referred to the outpatient unit Centre of Hypertension and Cardiovascular Prevention of L?Aquila 2. = 18 and = 75 years of age 3. Non-diabetic 4. SBP between 140 and 159 mmHg or DBP between 90 and 99 mmHg 5. Body mass index between 19 and 31 kg/m2
Exclusion criteria
Exclusion criteria: 1. Being an employee of the Department of Internal Medicine and Public Health of the University of L'Aguila 2. Except for grade I hypertension no additional cardiovascular risk factors (including a recorded history of coronary infarction, vascular surgery, transient ischemic attack, left ventricular hypertrophy or cardiac arrhythmia or apparent family history of cardiovascular diseases) 3. A recorded history or current metabolic diseases, chronic gastrointestinal disorders, cardiovascular or renal disease or diabetes mellitus 4. Indications for compromised liver or kidney function. 5. Currently on a medically prescribed diet or slimming diet 6. Subjects with irregular pulse or pulse =50 or =100 bpm 7. Reported intense sporting activities > 10 hours/week 8. Subjects who are taking prescribed medical treatment that is likely to affect blood pressure (or who have been taking such medication in the past) 9. Use of systemic antibiotics in the period of 3 months prior to the study 10. Recent blood donation i.e. 1 month (male subjects) or 2 months (females) prior to the study and no planned blood donation during the study period 11. Reported intolerance or allergy to constituents of the study products 12. Reported lactating, pregnant or wishing to become pregnant during the study 13. Reported weight change ± 10% during a period of 6 months prior to the study 14. Reported participation in another biomedical study 3 months before the start or during the study 15. Reported smoking during a period of one year prior to the study or planning to smoke during the study 16. Reported participation in night shift work 17. Female participants not in post-menopausal phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Flow-mediated dilatation of the brachial artery of the dominant arm was measured by ultrasonography with a non-invasive probe at approximately 5-10 cm above the elbow. After a 1-minute baseline measurement a cuff placed at the forearm just below the elbow will be inflated at 250 mmHg for 5 minutes and then deflated and the maximal dilation of the brachial artery will be measured. 2. Digital volume pulse measurements were evaluated by a validated finger photoplethysmographic device (a little clip on the finger). Three consecutive recordings were obtained in the index finger of the non-dominant hand with participants resting 15 min in supine position. 3. Office blood pressure measurements were recorded by a validated oscillometric device with appropriately sized cuffs (Omron 705 CP; Omron Matsusaka Co. Ltd., Matsusaka-City, Japan) on the dominant upper arm. For this purpose, patients rested 15 min in supine position. Then, the first blood pressure measurement was discarded and the subsequent three consecutive BP readings, taken at 5-min intervals, were recorded. The average of these latter measures was considered for statistical analysis. All outcomes were measured on day 7 and day 8 of each of the two intervention phases. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In all individuals, a routine hematochemical check was performed by standard methods after each active treatment phase. Plasma glucose and insulin, serum total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglyceride levels were assessed in the clinical chemistry laboratory using routine procedures. Plasma glucose and insulin values were used to calculate the index of insulin resistance, homeostasis model assessment of insulin resistance (HOMA-IR). 2. Further, blood samples were collected for clinical chemical analyses of vascular function and inflammation (endothelial activation): C-reactive protein, E-selectin, ICAM-1, Endothelin-1 and VCAM-1 levels (immuno-enzymatic methods - ELISA kits), including assessment of the number of circulating endothelial progenitor cells (counted manually in 10 randomly selected microscopic fields by two independent investigators with an inverted fluorescence microscope, after some laboratory phases). All outcomes were measured on day 7 and day 8 of each of the two intervention phases. | — |
Countries
Italy
Outcome results
None listed