NCT01682291

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

1.9 years

First QC Date

September 5, 2012

Last Update Submit

March 6, 2013

Conditions

Prehypertension

Keywords

PrehypertensionLife-style modificationsDietary supplementation

Outcome Measures

Primary Outcomes (1)

  • Changes in blood pressure levels as compared with baseline at 1 year

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

    1 year

Secondary Outcomes (1)

  • Reasons for treatment discontinuation

    1 year

Study Arms (2)

Life-style modifications

ACTIVE COMPARATOR

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

Dietary supplements

ACTIVE COMPARATOR

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

Interventions

Life-style modificationsBEHAVIORAL

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)

Also known as: Adoption of healthy lifestyles
Life-style modifications
Dietary supplementsDIETARY_SUPPLEMENT

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)

Also known as: Life-style modifications and dietary supplements
Dietary supplements

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza University

Rome, 00166, Italy

Location

Related Publications (1)

  • Pelliccia F, Pasceri V, Marazzi G, Arrivi A, Cacciotti L, Pannarale G, Speciale G, Greco C, Gaudio C. Randomised, double-blind, placebo-controlled, assessment of the efficacy and safety of dietary supplements in prehypertension. J Hum Hypertens. 2017 Oct;31(10):647-653. doi: 10.1038/jhh.2017.35. Epub 2017 Apr 27.

    PMID: 28447625DERIVED

MeSH Terms

Conditions

Prehypertension

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Francesco Pelliccia, MD

    Sapienza University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

+39064997f.pelliccia@mclink.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 10, 2012

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2017

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

IT(1)