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Prehypertension and Dietary Supplements - The PYRAMIDS Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01682291
First received: September 5, 2012
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Prehypertension
Behavioral: Life-style modifications
Dietary Supplement: Dietary supplements
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Pre-hYpertension tReament With A coMbinatIon of Dietary Supplements and Life-style Modifications

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Changes in blood pressure levels as compared with baseline at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Changes in systolic and diastolic blood pressure levels as compared with baseline at 1 year


Secondary Outcome Measures:
  • Reasons for treatment discontinuation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Reasons for treatment discontinuation during the 1-year study period


Estimated Enrollment: 500
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 5, 2012
Last Updated: March 6, 2013
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014