Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial

Abstract

IntroductionThe 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 analysisHere 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 disseminationThis 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.

Effects of Cocoa-Rich Chocolate on Blood Pressure, Cardiovascular Risk Factors, and Arterial Stiffness in Postmenopausal Women: A Randomized Clinical Trial

“…The methods used for measuring other variables, such as physical activity, alcohol consumption, and smoking habits, are described in the previously published study protocol [29].…”

“…The statistical analysis was carried out following the study protocol [29]. The data were verified for normal distribution and most data were considered normally distributed.…”

Cocoa-Rich Chocolate and Quality of Life in Postmenopausal Women: A Randomized Clinical Trial

“…The clinical trial has been registered in clinicaltrials.gov as NCT03492983. The protocol of the trial has been published [ 21 ].…”

“…Moreover, the history of the following morbidities was also recorded: gestational diabetes, hypertension and dyslipidaemia without pharmacological treatment and diagnosed depression. A more detailed description of the methodology and of the assessment of other variables, such as physical activity, alcohol consumption and smoking, is included in the trial protocol [ 21 ].…”

Duloxetine combined with intra-articular injection versus intra-articular injection alone for pain relief in knee osteoarthritis: a study protocol for a randomised controlled trial

“…The allocation sequence will be generated by an independent researcher before the inclusion of the first participant. 34 After randomisation, all patients will be randomly assigned to the experimental group IA (HA+CS) combined with oral duloxetine or control group (IA (HA+CS)) in a distribution ratio of 1:1. One assessor will be responsible for the pre-trial evaluation of eligibility, and another assessor will be responsible for the post-intervention evaluation.…”