Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial.
Irene A Garcia-YuLuis Garcia-OrtizManuel Angel Gomez-MarcosRosario Alonso-DominguezJesus Gonzalez-SanchezSara Mora-SimonSusana González-ManzanoEmiliano Rodriguez-SanchezJose A Maderuelo-FernandezJose I Recio-RodriguezPublished in: BMJ open (2018)
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.
Keyphrases
- clinical trial
- postmenopausal women
- public health
- open label
- healthcare
- double blind
- bone mineral density
- study protocol
- phase ii
- mental health
- randomized controlled trial
- health information
- phase iii
- health promotion
- quality improvement
- big data
- systematic review
- placebo controlled
- machine learning
- drug administration