Hypertension Arterial
Conditions
Keywords
Rosmarinus officinalis L, male hypertensive patients, hypertension, infusion
Brief summary
This study assessed the antihypertensive effect of rosemary tea through a placebo-controlled clinical study, angiotensin-converting enzyme (ACE) inhibition analysis, and in silico evaluation of interactions between rosemary bioactive compounds and the AT1R (Angiotensin II Type 1 Receptor). A randomized, double-blind, placebo-controlled trial was conducted in 54 male patients with mild hypertension. Participants were assigned to receive either rosemary infusion (n = 27) or placebo (n = 23) for 45 days. Ambulatory blood pressure monitoring wass used to evaluate blood pressure parameters. Serum ACE activity was measured at baseline and after the intervention using FAPGG hydrolysis. Molecular docking simulations were performed using the Dock 4.2 software.
Interventions
DIETARY_SUPPLEMENTRosemary extract infusion
Infusion prepared from 2g of rosemary leaves Administered orally, 1 cup (100 mL) per day Duration: 6 weeks
DIETARY_SUPPLEMENTPlacebo
Infusion with color and taste similar to rosemary, without active extract Administered orally, 1 cup (100 mL) per day Duration: 6 weeks
Sponsors
awatef Sassi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male participants aged 28-65 years * Mild hypertension, defined as systolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg, according to ESC/ESH 2018 guidelines * No history of chronic diseases * Not currently taking antihypertensive medications, other drugs, or dietary supplements * Body mass index (BMI) within the screening range at recruitment * Provided written informed consent
Exclusion criteria
* Secondary hypertension * History of cardiovascular disease, diabetes mellitus, renal failure, autoimmune disease, or major gastrointestinal disorders * Current use of medications affecting blood pressure * Extreme body mass index (BMI) values * Significant dietary changes or irregular physical activity in the previous six months * Alcohol consumption or use of illicit drugs * Inability or unwillingness to maintain usual diet and lifestyle during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of ambulatory blood pressure | 6 weeks | ABPM was utilized to improve the accuracy of the clinical trial while minimizing the required number of participants. Blood pressure mea- surements were taken at the brachial artery using a Holter SunTech Medical Oscar 2 device (INC S07Air Port Blvd, Suite 117, Morrisville, NC, USA) to monitor BP over a 24-hour period. The device was set to record BP every 30 min during the day and every hour at night. The cuff was placed on the non-dominant arm, enabling the participants to carry on with their normal activities. They were instructed to stay still during cuff inflation. The sleep and wake times for programming the Holter device were established based on a question asked to the subjects during their visit. These measurements were recorded on Day 0 (D0) and Day 45 (D45) to assess the impact of the rosemary infusion on blood pressure. We assessed the following blood pressure parameters: 24-h, daytime, and nighttime SBP and DBP, mean blood pressure (MBP), heart rate (HR), and nocturnal d |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of serm angiotensin-converting enzyme activity | 6 weeks | Serum angiotensin-converting enzyme (ACE) activity was determined in men with grade 1 hypertension using serum samples collected at baseline and after six weeks of daily consumption of either rosemary infusions or a placebo. It was measured using the ACE Liquid reagent kit (Sentinel Diagnostics, Italy) on an automated clinical chemistry analyzer (Beckman Coulter AU 700, USA). The method is based on the enzymatic hydrolysis of the synthetic substrate FAPGG (furylacryloyl-phenylalanyl-glycyl-glycine). ACE catalyzes the cleavage of FAPGG, resulting in a decrease in absorbance at 340 nm, which is directly proportional to the ACE activity in the sample. Intra- and inter-assay precision coefficient of variation (CV) of the Beckman Coulter AU 700 Sentinel Diagnostics ACE values are 2.6% and 2.9%, respectively at 40 UI/L. The ACE activity measurement exhibits excellent linearity across the range of 5.8 U/L to 120 U/L, ensuring accurate quantification within this interval. Adults' normal ACE |
| Biochemical Analysis and Assessment | 6 weeks | Blood samples were collected from the cubital vein of subjects both at baseline and after the study, following a 12-h fasting period. The samples were drawn into three distinct tubes: an EDTA-coated tube, a heparin-coated tube, and a sodium fluoride/potassium oxalate-coated tube. These samples were immediately subjected to centrifugation for 20 min at 3000 rpm, then stored at -80 ◦C until further analysis. Plasma aliquots were transferred to the biochemistry laboratory for the determination of various biochemical parameters and ionic con- stituents in the blood, including ASAT, ALAT, total bilirubin, direct bilirubin, γ-GT, alkaline phosphatase, cholesterol, triglycerides, HDL, LDL, glucose, urea, creatinine, uric acid, albumin, Na+, and K+. Ana- lyses were conducted at the Biochemistry Department of Farhat Hached Hospital in Sousse using the Unicell DXC 600 Synchron analyzer by Beckman Coulter. LDL cholesterol levels were calculated using the Friedewald formula. |
| Evaluation Perceived Benefits of Rosemary infusion | 6 weeks | During the intervention period, participants were instructed to report any noticeable changes in health status associated with the use of rosemary infusion. This approach enabled the investigator to monitor safety and collect subjective observations related to the intervention. |
Countries
Tunisia
Outcome results
None listed