Evidence map›Paper›PMID 30552275›Full record

ArticleBMJ open2018

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

Irene A Garcia-Yu, Luis Garcia-Ortiz, Manuel A Gómez-Marcos, Rosario Alonso-Dominguez, Jesus Gonzalez-Sanchez, Sara Mora-Simon, Susana González-Manzano, Emiliano Rodriguez-Sanchez, Jose A Maderuelo-Fernandez, Jose I Recio-Rodriguez

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03492983 (Effect of High Cocoa Content Chocolate on Vascular Function, Body Composition, Health-related Quality of Life and Cognitive Performance in Postmenopausal Women.), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03492983 nacompletednot on this map

Effect of High Cocoa Content Chocolate on Vascular Function, Body Composition, Health-related Quality of Life and Cognitive Performance in Postmenopausal Women.

TypeinterventionalSponsorFundacion para la Investigacion y Formacion en Ciencias de la SaludRan2018 to 2019Enrolled140ConditionsPostmenopausal WomenArmsIntervention group
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Irene A Garcia-YuPrimary Health Care Research Unit, La Alamedilla Health Center, Institute of Biomedical Research of Salamanca (IBSAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.
Luis Garcia-OrtizPrimary Health Care Research Unit, La Alamedilla Health Center, Institute of Biomedical Research of Salamanca (IBSAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.
Manuel A Gómez-MarcosPrimary Health Care Research Unit, La Alamedilla Health Center, Institute of Biomedical Research of Salamanca (IBSAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.ORCID 0000-0003-0133-6123
Rosario Alonso-DominguezPrimary Health Care Research Unit, La Alamedilla Health Center, Institute of Biomedical Research of Salamanca (IBSAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.ORCID 0000-0002-5816-4070
Jesus Gonzalez-SanchezPrimary Health Care Research Unit, La Alamedilla Health Center, Institute of Biomedical Research of Salamanca (IBSAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.
Sara Mora-SimonPrimary Health Care Research Unit, La Alamedilla Health Center, Institute of Biomedical Research of Salamanca (IBSAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.
Susana González-ManzanoDepartment of Analytical Chemistry, University of Salamanca, Salamanca, Spain.
Emiliano Rodriguez-SanchezPrimary Health Care Research Unit, La Alamedilla Health Center, Institute of Biomedical Research of Salamanca (IBSAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.
Jose A Maderuelo-Fernandez *Primary Health Care Research Unit, La Alamedilla Health Center, Institute of Biomedical Research of Salamanca (IBSAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.
Jose I Recio-Rodriguez *Primary Health Care Research Unit, La Alamedilla Health Center, Institute of Biomedical Research of Salamanca (IBSAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 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.

Indexed as

ChocolateDietBlood PressureBody CompositionCacaoCognitionFemaleHumansLife StyleMiddle AgedPolyphenolsPostmenopauseQuality of LifeRandomized Controlled Trials as TopicVascular StiffnessPolyphenolsarterial pressurebody compositionchocolatepostmenopausequality of lifevascular stiffness

Identifiers

PMID30552275
PMCPMC6303642

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.