RT info:eu-repo/semantics/article
T1 Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial
A1 Garcia Yu, Irene A. .
A1 García Ortiz, Luis
A1 Gómez Marcos, Manuel A.
A1 Alonso Domínguez, Rosario
A1 González Sánchez, Jesús
A1 Mora Simón, Sara
A1 González Manzano, Susana .
A1 Rodríguez Sánchez, Emiliano
A1 Maderuelo Fernández, José A.
A1 Recio Rodríguez, José I.
K1 Nutrición
K1 Nutrition
AB Introduction The intake of polyphenols has certain healthbenefits. This study will aim to assess the effect of addinga daily amount of chocolate high in cocoa content andpolyphenols to the normal diet on blood pressure, vascularfunction, cognitive performance, quality of life and bodycomposition in postmenopausal women.Methods and analysis Here we plan a randomisedclinical trial with two parallel groups involving atotal of 140 women between 50 and 64 years in thepostmenopausal period, defined by amenorrhoea of atleast 12 consecutive months. The main variable will bethe change in blood pressure. Secondary variables willbe changes in vascular function, quality of life, cognitiveperformance and body composition. The interventiongroup will be given chocolate containing 99% cocoa, withinstructions to add 10 g daily to their normal diet for 6months. The daily nutritional contribution of this amountof chocolate is 59 kcal and 65.4 mg of polyphenols. Therewill be no intervention in the control group. All variableswill be measured at the baseline visit and 3 and 6 monthsafter randomisation, except cognitive performance andquality of life, which will only be assessed at baseline andat 6 months. Recruitment is scheduled to begin on 1 June2018, and the study will continue until 31 May 2019.Ethics and dissemination This study was approvedby the Clinical Research Ethics Committee of the HealthArea of Salamanca, Spain (‘CREC of Health Area ofSalamanca’), in February 2018. A SPIRIT checklist isavailable for this protocol. The clinical trial has beenregistered at ClinicalTrials. gov provided by the US NationalLibrary of Medicine, number NCT03492983. The resultswill be disseminated through open access peer-reviewedjournals, conference presentations, broadcast media and apresentation to stakeholders.
PB BMJ
SN 2044-6055
YR 2018
FD 2018-12
LK http://hdl.handle.net/10259/5046
UL http://hdl.handle.net/10259/5046
LA eng
NO Gerencia Regional de Castilla y León (GRS 1583/B/17
DS Repositorio Institucional de la Universidad de Burgos
RD 19-abr-2024