2026-04-27T22:56:24Zhttps://riubu.ubu.es/oai/requestoai:riubu.ubu.es:10259/50462021-11-10T09:53:33Zcom_10259_4996com_10259_3989com_10259.4_106com_10259_2604col_10259_4999
Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial
Garcia Yu, Irene A. .
García Ortiz, Luis
Gómez Marcos, Manuel A.
Alonso Domínguez, Rosario
González Sánchez, Jesús
Mora Simón, Sara
González Manzano, Susana .
Rodríguez Sánchez, Emiliano
Maderuelo Fernández, José A.
Recio Rodríguez, José I.
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.
2019-01-09T09:10:56Z
2019-01-09T09:10:56Z
2019-01-09T09:10:56Z
2018-12
info:eu-repo/semantics/article
2044-6055
http://hdl.handle.net/10259/5046
10.1136/bmjopen-2018-024095
eng
BMJ Open. 2018, V. 8, n. 12, e024095
http://dx.doi.org/10.1136/bmjopen-2018-024095
info:eu-repo/grantAgreement/JCyL/GRS 1583-B-17
http://creativecommons.org/licenses/by-nc/4.0/
info:eu-repo/semantics/openAccess
Attribution-NonCommercial 4.0 International
BMJ