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PYRAMIDSCombinaison de compléments alimentaires et de modifications du mode de vie pour la gestion de la préhypertension

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But de l'étude

Cette étude vise à prévenir la préhypertension en associant des compléments alimentaires et des modifications du mode de vie, en observant les changements de votre tension artérielle après un an par rapport au début.

Ce qui est testé

Changements de style de vie sains

+ Complément Alimentaire Quotidien sous Forme de Pilule

ComportementalComplément alimentaire
Qui peut participer

Maladies Cardiovasculaires

+ Maladies vasculaires

+ Préhypertension

À partir de 18 ans
+2 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude de prévention

Phase 4
Interventionnel
Date de début : janvier 2014
Voir le détail du protocole

Résumé

Sponsor principalUniversity of Roma La Sapienza
Contacts de l'étudeFrancesco Pelliccia, MDVoir plus de contacts
Dernière mise à jour : 7 mars 2013
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 janvier 2014

Date à laquelle le premier participant a commencé l'étude.

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)

Sponsor principalUniversity of Roma La Sapienza
Contacts de l'étudeFrancesco Pelliccia, MDVoir plus de contacts
Dernière mise à jour : 7 mars 2013
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

500 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Prévention

Cette étude cherche à prévenir l'apparition d'une maladie ou d'un trouble chez des personnes qui ne l'ont pas encore développé. Elles concernent souvent des personnes à risque et testent des vaccins, des changements de mode de vie ou des traitements préventifs.


Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies CardiovasculairesMaladies vasculairesPréhypertension

Critères

Un critère d'inclusion nécessaire pour participer
Otherwise healthy subjects with "prehypertension", that is blood pressures ranging from 120-139 mmHg systolic and/or 80-89 mmHg diastolic-

Un critère d'exclusion empêche la participation
Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Comparateur actif
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)

Groupe II

Comparateur actif
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)

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Sapienza University

Rome, ItalyOuvrir Sapienza University dans Google Maps
Suspendu1 Centres d'Étude