Berberis Vulgaris Consumption and Blood Pressure

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StatussPieņemšana darbā

Sponsori

Shahid Beheshti University

KLĪNISKĀ IZPĒTE: NCT04084847

BioSeek: nct04084847

Atslēgvārdi

Abstrakts

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

Pēdējoreiz pārbaudīts:	03/31/2020
Pirmais iesniegtais:	09/02/2019
Paredzētā reģistrācija iesniegta:	09/06/2019
Pirmais izlikts:	09/09/2019
Pēdējais atjauninājums iesniegts:	04/10/2020
Pēdējā atjaunināšana ievietota:	04/13/2020
Faktiskais studiju sākuma datums:	09/17/2019
Paredzamais primārās pabeigšanas datums:	03/18/2020
Paredzamais pētījuma pabeigšanas datums:	05/31/2020

Stāvoklis vai slimība

Blood Pressure

Cardiovascular Risk Factor

Lipid Profile

Iejaukšanās / ārstēšana

Dietary Supplement: Barberry

Dietary Supplement: placebo

Fāze

Roku grupas

Roka	Iejaukšanās / ārstēšana
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

Atbilstības kritēriji

Vecums, kas piemērots studijām	20 Years Uz 20 Years
Dzimumi, kas ir piemēroti studijām	All
Pieņem veselīgus brīvprātīgos	Jā
Kritēriji	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

Rezultāts

Primārie rezultāti

1. blood pressure [at 8 weeks]

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

Sekundārie iznākuma mērījumi

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

Atslēgvārdi

iekaisums

berberis taronensis

parastā bārbele

berberis