Berberis Vulgaris Consumption and Blood Pressure

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StatusVrbovanje

Sponzori

Shahid Beheshti University

KLINIČKO ISPITIVANJE: NCT04084847

BioSeek: nct04084847

Ključne riječi

Sažetak

The aim of this study is to investigate the effect of barberry consumption on systolic and diastolic blood pressure, serum lipids, and inflammatory status. The study will involve cases having elevated BP (129/ < 85) and known hypertensive patients on medical treatment. Seventy people will be randomized into two groups, including intervention (barberry) or placebo groups.

Before and after of 8 week intervention, 24-hour ambulatory blood pressure monitoring will be done and fasting venous blood sample will be taken to measure plasma lipids. In addition, 24-hour urine will be collected to measure its sodium content and estimate sodium intake.

Datumi

Posljednja provjera:	03/31/2020
Prvo podneseno:	09/02/2019
Predviđena prijava poslana:	09/06/2019
Prvo objavljeno:	09/09/2019
Posljednje ažuriranje poslano:	04/10/2020
Posljednje ažuriranje objavljeno:	04/13/2020
Stvarni datum početka studija:	09/17/2019
Procijenjeni datum primarnog završetka:	03/18/2020
Procijenjeni datum završetka studije:	05/31/2020

Stanje ili bolest

Blood Pressure

Cardiovascular Risk Factor

Lipid Profile

Intervencija / liječenje

Dietary Supplement: Barberry

Dietary Supplement: placebo

Faza

Grupe ruku

Ruka	Intervencija / liječenje
Active Comparator: Barberry Daily consumption of barberry in powder form.	Dietary Supplement: Barberry 10 grams of barberry powder will be consumed daily for 8 weeks.
Placebo Comparator: placebo Daily consumption of placebo powder.	Dietary Supplement: placebo Placebo powder

Kriterij prihvatljivosti

Dobni uvjeti za studiranje	20 Years Do 20 Years
Spolovi koji ispunjavaju uvjete za studij	All
Prihvaća zdrave volontere	Da
Kriteriji	Inclusion Criteria: - willingness to participate in the study - age between 20-65 years - having elevated BP (129/ < 85) and known hypertensive patients on medical treatment - at least one other classical cardiovascular disease risk factors, including hyperlipidemia or diabetes mellitus Exclusion Criteria: - Unwillingness to continue participation - BMI> 30 - patients on nitrates - high doses of statins consumption (Atorvastatin>40 mg/day or Rosuvastatin>20 mg/day) - consumption of vitamins or minerals supplements during past month - Chronic kidney disease stage 4 or 5

Ishod

Primarne mjere ishoda

1. blood pressure [at 8 weeks]

mean of systolic and diastolic blood pressure of participants measured by ambulatory 24 hour blood pressure monitoring

Sekundarne mjere ishoda

1. lipid profile [at 8 weeks]

plasma TC, LDL-C, HDL-C, TG

2. plasma NOx [at 8 weeks]

concentration of nitrite and nitrate in plasma

3. Inflammatory cytokine [at 8 weeks]

Plasma Interleukin-6

Berberis Vulgaris Consumption and Blood Pressure

Ključne riječi

upala

berberis taronensis

šimširika

žutika