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Prehypertension and Dietary Supplements - The PYRAMIDS Study (PYRAMIDS)

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ClinicalTrials.gov Identifier: NCT01682291
Recruitment Status : Unknown
Verified March 2013 by Francesco Pelliccia, University of Roma La Sapienza.
Recruitment status was:  Not yet recruiting
First Posted : September 10, 2012
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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)


Condition or disease Intervention/treatment Phase
Prehypertension Behavioral: Life-style modifications Dietary Supplement: Dietary supplements Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Pre-hYpertension tReament With A coMbinatIon of Dietary Supplements and Life-style Modifications
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Life-style modifications

Lifestyle modifications will include:

Weight loss of as little as 10 lbs (4.5 kg) Adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan Dietary sodium should be reduced to no more than 2.4 g of sodium per day Regular aerobic physical activity (at least 30 minutes per day)

Behavioral: Life-style modifications
Weight loss of as little as 10 lbs (4.5 kg) Adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan Dietary sodium should be reduced to no more than 2.4 g of sodium per day Regular aerobic physical activity (at least 30 minutes per day)
Other Name: Adoption of healthy lifestyles
Active Comparator: Dietary supplements
Life-style modifications along with a novel combination of dietary supplements that 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)
Dietary Supplement: Dietary supplements
combined pill (1 capsule/day containing Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250 mg/day)
Other Name: Life-style modifications and dietary supplements


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Reasons for treatment discontinuation [ Time Frame: 1 year ]
    Reasons for treatment discontinuation during the 1-year study period


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Otherwise healthy subjects with "prehypertension", that is blood pressures ranging from 120-139 mmHg systolic and/or 80-89 mmHg diastolic-

Exclusion Criteria:

  • Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682291


Contacts
Contact: Francesco Pelliccia, MD +39064997 ext 123 f.pelliccia@mclink.it

Locations
Italy
Sapienza University Not yet recruiting
Rome, Italy, 00166
Contact: Francesco Pelliccia, MD    +39064997 ext 123    f.pelliccia@mclink.it   
Principal Investigator: Francesco Pelliccia, MD         
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Francesco Pelliccia, MD Sapienza University
More Information

Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01682291     History of Changes
Other Study ID Numbers: 450-B/2012/D
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by Francesco Pelliccia, University of Roma La Sapienza:
Prehypertension
Life-style modifications
Dietary supplementation

Additional relevant MeSH terms:
Prehypertension
Vascular Diseases
Cardiovascular Diseases