2026-04-28T01:51:48Zhttps://riubu.ubu.es/oai/request

oai:riubu.ubu.es:10259/50462021-11-10T09:53:33Zcom_10259_4996com_10259_3989com_10259.4_106com_10259_2604col_10259_4999

00925njm 22002777a 4500 dc Garcia Yu, Irene A. . author García Ortiz, Luis author Gómez Marcos, Manuel A. author Alonso Domínguez, Rosario author González Sánchez, Jesús author Mora Simón, Sara author González Manzano, Susana . author Rodríguez Sánchez, Emiliano author Maderuelo Fernández, José A. author Recio Rodríguez, José I. author 2018-12 Introduction The intake of polyphenols has certain health benefits. This study will aim to assess the effect of adding a daily amount of chocolate high in cocoa content and polyphenols to the normal diet on blood pressure, vascular function, cognitive performance, quality of life and body composition in postmenopausal women. Methods and analysis Here we plan a randomised clinical trial with two parallel groups involving a total of 140 women between 50 and 64 years in the postmenopausal period, defined by amenorrhoea of at least 12 consecutive months. The main variable will be the change in blood pressure. Secondary variables will be changes in vascular function, quality of life, cognitive performance and body composition. The intervention group will be given chocolate containing 99% cocoa, with instructions to add 10 g daily to their normal diet for 6 months. The daily nutritional contribution of this amount of chocolate is 59 kcal and 65.4 mg of polyphenols. There will be no intervention in the control group. All variables will be measured at the baseline visit and 3 and 6 months after randomisation, except cognitive performance and quality of life, which will only be assessed at baseline and at 6 months. Recruitment is scheduled to begin on 1 June 2018, and the study will continue until 31 May 2019. Ethics and dissemination This study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca, Spain (‘CREC of Health Area of Salamanca’), in February 2018. A SPIRIT checklist is available for this protocol. The clinical trial has been registered at ClinicalTrials. gov provided by the US National Library of Medicine, number NCT03492983. The results will be disseminated through open access peer-reviewed journals, conference presentations, broadcast media and a presentation to stakeholders. 2044-6055 http://hdl.handle.net/10259/5046 10.1136/bmjopen-2018-024095 Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial