Food Supplementation With Diuripres for Blood Pressure Modulation in Subjects With High-Normal Blood Pressure
Condition: High-Normal Blood Pressure
Study type: Interventional

Summary: 
      Cardiovascular diseases (CVDs) are the leading cause of mortality worldwide, reaching the 31%
      of deaths in 2012. CVDs represent also the major cause of disability in developed countries
      and has been estimated that their growing burden could lead to a global increase in loss of
      disability-adjusted life years (DALY), from a loss of 85 million DALYs of 1990 to a loss of ~
      150 million DALYs in 2020, becoming a major cause of no psychic responsible for lost
      productivity.

      Several risk factors contribute to the aetiology and development of CVD. These factors have
      been traditionally stratified into modifiable risk factors through the lifestyle changes or
      by taking a pharmacologic treatment (e.g. hypertension, smoking, diabetes mellitus,
      hypercholesterolemia) and not modifiable risk factors (age, male sex and family history).
      Essential hypertension is the most common modifiable risk factor in the general population,
      with a prevalence in Western Countries -including Italy- ranging between about 25-45%.

      Given the large prevalence of the disease of the general population, hypertension is
      responsible for the vast majority of CVD in individuals with different CV risk profiles,
      despite the availability of effective and well tolerated antihypertensive therapies. In this
      regard, several reports have shown that hypertensive patients often present additional CV and
      metabolic risk factors, mostly hypercholesterolemia, hypertriglyceridemia, metabolic syndrome
      and diabetes, which further contribute to increase the individual risk of developing
      hypertension-related complications, including stroke, end-stage renal disease, congestive
      heart failure, and CVD death. The concomitant presence of hypertension and dyslipidaemia is
      also responsible for the objective difficulty in achieving the recommended therapeutic
      targets for BP and cholesterol levels in a setting of clinical practice.

      Several pharmacological and non-pharmacological interventions have been proposed for
      ameliorating the relatively low rates of control of hypertension. Among these, an extensive
      use of nutrients and food supplements has been shown to provide favourable effects in the
      management and control of high-normal blood pressure (BP) (or pre-hypertension), that
      increases the risk of developing hypertension, cardiovascular diseases, and renal failure.
    

Detailed description: 
      Among food supplements largely used in this field, Orthosiphon stamineus Benth leaf extract
      has been recognized for its well-known diuretic properties; extract of hawthorn (Crataegus
      curvisepala Lind.) has been shown to exert a renal-protective effect in high salt-induced
      hypertension and extract of hibiscus (Hibiscus sabdariffa L.) is well known for its
      antihypertensive and vasodilator effect in human. Moreover, supplementation with magnesium
      has been recently found to play a critical role in BP regulation, through directly
      stimulating prostacyclin and nitric oxide formation, modulating endothelium-dependent and
      endothelium-independent vasodilation, reducing vascular tone and reactivity, and preventing
      vascular injury via its antioxidant and anti-inflammatory functions.

      The objective of this study is to evaluate the effect of dietary supplementation of a
      combined food supplement (NUT) containing magnesium, standardized extract of orthosiphon
      (Orthosiphon stamineus Benth), standardized extract of hawthorn (Crataegus curvisepala Lind.)
      and standardized extract of hibiscus (Hibiscus sabdariffa L.) compared to placebo, on blood
      pressure and other markers of vascular aging in subjects with high-normal blood pressure.
    

Intervention name(s): Dietary Supplement; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Dietary supplement formulated with magnesium, standardized extract of orthosiphon, standardized extract of hawthorn and standardized extract of hibiscus. Each tablet contains: 0.1 g magnesium, 0.25 g standardized extract of orthosiphon (Orthosiphon stamineus Benth), 0.16 standardized extract of hawthorn (Crataegus curvisepala Lind.) and 0.08 g standardized extract of hibiscus (Hibiscus sabdariffa L.).
Oral administration: 2 tablets/day at evening meal; Oral administration: 2 tablets/day at evening meal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment