Prehypertension and Dietary Supplements - The PYRAMIDS Study

NCT ID: NCT01682291

Last Updated: 2013-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-12-31

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 Description

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 a disease category. Rather, it identifies individuals at high risk of developing hypertension, so that both patients and clinicians are alerted to this risk and encouraged to intervene and prevent or delay the disease from developing.
• Individuals who are prehypertensive are not candidates for drug therapy based on their level of BP and should be firmly and unambiguously advised to practice lifestyle modification in order to reduce their risk of developing hypertension.
• Moreover, individuals with prehypertension, who also have diabetes or kidney disease, should be considered candidates for appropriate drug therapy if a trial of lifestyle modification fails to reduce their BP to 130/80 mmHg or less.

Lifestyle Modifications. The goal for individuals with prehypertension and no compelling indications is to lower BP to normal levels with lifestyle changes, and prevent the progressive rise in BP using the recommended lifestyle modifications.

Also, adoption of healthy lifestyles is an indispensable part of the management of those with hypertension.

Lifestyle modifications include:

• Weight loss of as little as 10 lbs (4.5 kg) reduces BP and/or prevents hypertension
• Adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan94 which is a diet rich in fruits, vegetables, and low fat dairy products
• Dietary sodium should be reduced to no more than 100 mmol per day (2.4 g of sodium).
• Regular aerobic physical activity such as brisk walking at least 30 minutes per day
• Alcohol intake should be limited

Dietary Approaches to Stop Hypertension. The first-line approach to hypertension refractory to lifestyle modification remains pharmacologic therapy in combination with the low-salt DASH diet. However, a wide variety of alternative therapies are available for using to improve BP control. Dietary supplements and modification, as well as herbal supplements, may be useful under the right circumstances. Unfortunately, the efficacy of adding dietary, herbal, or alternative therapies is not well established. While combinations of antihypertensive drugs from different classes is a recommended approach that results in an additive benefit, it is not clear whether combinations of herbal or dietary supplements will also be additive.

Many of the studies evaluating the supplements referenced here are small and data are often derived from pooled analysis. In particular, studies to date evaluating garlic as well as many of the alternative approaches have significant limitations in study design. Should they prove efficacious and safe their use as a first-line therapy may come into play Thus, it remains unknown, however, whether the use of dietary supplements in association with life style interventions has any additive effect in subjects with Pre-hypertension.

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)

Conditions

Prehypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Life-style modifications

Intervention Type: BEHAVIORAL

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)

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)

Group Type: ACTIVE_COMPARATOR

Dietary supplements

Intervention Type: DIETARY_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)

Interventions

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)

Intervention Type: BEHAVIORAL

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)

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Adoption of healthy lifestyles; Life-style modifications and dietary supplements

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Francesco Pelliccia

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Pelliccia, MD

Role: PRINCIPAL_INVESTIGATOR

Sapienza University

Locations

Sapienza University

Rome, , Italy

Countries

Italy

Central Contacts

Francesco Pelliccia, MD

Role: CONTACT

f.pelliccia@mclink.it

+39064997 ext. 123

Facility Contacts

Francesco Pelliccia, MD

Role: primary

f.pelliccia@mclink.it

+39064997 ext. 123

References

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.

Reference Type: DERIVED

PMID: 28447625 (View on PubMed)

Other Identifiers

450-B/2012/D

Identifier Type: -

Identifier Source: org_study_id