Clinical Trial: Prehypertension and Dietary Supplements - The PYRAMIDS Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Pre-hYpertension tReament With A coMbinatIon of Dietary Supplements and Life-style Modifications

Brief Summary:

The primary objective of this study is to compare the efficacy and tolerability of a life-style modifications protocol versus a protocol including life-style modifications along with a novel combination of dietary supplement in the management of subjects diagnosed as having pre-hypertension.

The novel formulation includes: Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250 mg/day)

Detailed Summary:

Prehypertension. Prehypertension is an American classification for those subjects with a normal-elevated blood pressure (BP) that does not reach the level considered to be hypertension.

Because of the new data on lifetime risk of hypertension and the impressive increase in the risk of cardiovascular complications associated with levels of BP previously considered to be normal, the JNC 7 report has introduced a new classification that includes the term "prehypertension" for those with BPs ranging from 120-139 mmHg systolic and/or 80-89 mmHg diastolic.

This new designation is intended to identify those individuals in whom early intervention by adoption of healthy lifestyles could reduce BP, decrease the rate of progression of BP to hypertensive levels with age, or prevent hypertension entirely.

Data from the 1999 and 2000 National Health and Nutrition Examination Survey (NHANES III) estimated that the prevalence of prehypertension among adults in the United States was approximately 31%. The prevalence is higher among men than women (39 and 23 percent, respectively).] People with prehypertension are at a higher risk for developing hypertension and target organ damages (i.e. left ventricular hypertrophy), as compared to people with normal blood pressure. Furthermore, similar to hypertension, prehypertension can increase the risk for heart attacks, strokes, congestive heart failure, and renal failure. Researchers have found that a prehypertensive person is 3 times more likely to have a heart attack and 1.7 times more likely to have heart disease than a person with normal blood pressure.

Management of Prehypertension.

• Prehypertension is not
  Sponsor: University of Roma La Sapienza
  

  Current Primary Outcome: Changes in blood pressure levels as compared with baseline at 1 year [ Time Frame: 1 year ]

  Changes in systolic and diastolic blood pressure levels as compared with baseline at 1 year
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome: Reasons for treatment discontinuation [ Time Frame: 1 year ]

  Reasons for treatment discontinuation during the 1-year study period
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: University of Roma La Sapienza
  

  Dates:
  Date Received: September 5, 2012
  Date Started: January 2014
  Date Completion: December 2017
  Last Updated: March 6, 2013
  Last Verified: March 2013