NUTSNUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)
Walnuts 30 grams
+ Walnuts 60 grams
Maladies Cardiovasculaires+2
+ Maladies métaboliques
+ Maladies nutritionnelles et métaboliques
Étude de prévention
Résumé
Date de début de l'étude : 14 octobre 2019
Date à laquelle le premier participant a commencé l'étude.Increased consumption of nuts improves the levels of lipid risk factors associated with cardiovascular disease and consistently relates to lower risk of cardiovascular disease (CVD) in prospective cohort studies. The estimates of health effects and potential population benefits of increased consumption of nuts are based mostly on observational data and there remains considerable uncertainty about whether higher intake of nuts will actually reduce cardiovascular outcomes. To address this uncertainty will require a well-conducted, adequately powered, large-scale, randomised control trial that tests the causal relationship between nut intake and the risk of cardiovascular diseases. We hereby designed a 6-month walnut supplementation trial in a rural area of China with high rates of CVD, to obtain data to support and help to refine the design of a future long-term large RCT testing the effect of nut supplementation on CVD risk. The main objectives of the current trial are to assess the acceptability and adherence to two different doses of walnut supplementation (30 and 60 grams per day). The exploratory objectives are to determine the effects of walnut supplementation on cardiovascular risk factors including blood lipids, fasting glucose, and body weight.
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.210 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: 1. A history of CVD, defined on the basis of a prior hospitalisation for a myocardial infarction or stroke, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (with or without stenting), peripheral revascularization (angioplasty or surgery), symptomatic with documented hemodynamically-significant carotid or peripheral vascular disease, or amputation secondary to vascular disease, OR 2. Male aged \>60 years, or female aged\>65 years, AND With at least two of the following risk factors: 1. Type 2 diabetes requiring treatment with at least two oral anti-hyperglycaemic agents and/or insulin 2. Systolic blood pressure \> 140 mmHg while on one or more antihypertensive agents 3. Current daily smoking 4. Dyslipidaemia defined as HDL-cholesterol\<1.0mmol/L or LDL-cholesterol\>6.0mmol/L 5. Micro or macro albuminuria Exclusion Criteria: 1. Allergic to nuts (history of food allergy with hypersensitivity to any of the components of nuts) 2. Other serious medical condition that prevents nut consumption (e.g. digestive disease with fat intolerance) 3. Any medical condition thought to limit survival to less than 1 year 4. Difficulty with consuming nuts (e.g. dental health issues that prevent chewing walnuts) 5. Unwilling to consume nuts
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalObjectifs 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