NUTSNUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)
Walnuts 30 grams
+ Walnuts 60 grams
Enfermedades Cardiovasculares
+ Enfermedades metabólicas
+ Enfermedades Nutricionales y Metabólicas
Estudio de Prevención
Resumen
Fecha de inicio: 14 de octubre de 2019
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 210 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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 Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
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