Prehypertension and Dietary Supplements - The PYRAMIDS Study
This study is not yet open for participant recruitment.
Verified March 2013 by University of Roma La Sapienza
Sponsor:
University of Roma La Sapienza
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
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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
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 June 17, 2013