Clinical trial NCT03492983: Effect of High Cocoa Content Chocolate on Health in Postmenopausal Women.
Official title: Effect of High Cocoa Content Chocolate on Vascular Function, Body Composition, Health-related Quality of Life and Cognitive Performance in Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Women
Keywords: Cocoa
Vascular function
Body composition
Quality of life
Cognitive performance
Postmenopausal women
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Castilla-León Health Service
First posted: 2018-04-10
Enrollment: 140
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized clinical trial aimed at postmenopausal women aged 50 to 64 years old selected in urban primary care centers of two centers (Spain). Its objective is to evaluate the effects of the additional intake of high cocoa content chocolate on blood pressure, vascular function, body composition, quality of life and cognitive performance.

Detailed description: * Objective: To assess the effect at 6 months of the additional intake of 10 g/day of high cocoa content chocolate for 6 months on blood pressure, vascular function, body composition, quality of life and cognitive performance in postmenopausal women.
* Design and setting: A randomized clinical trial of two parallel groups. Population: 140 postmenopausal women, 50 to 64 aged will be included, selected by consecutive sampling in two primary care centers.
* Measurements and intervention: Vascular function (blood pressure, augmentation index and Cardio-Ankle Vascular Index), body composition and health-related quality of life will be evaluated. The intervention group will receive a daily supplement of high cocoa content chocolate for 6 months.

Eligibility criteria: Inclusion Criteria:

* Women in postmenopausal period defined as 12 consecutive months of amenorrhea.

Exclusion Criteria:

* Older than 65 years.
* Cardiovascular disease (acute myocardial infarction, stroke).
* Arterial hypertension on treatment.
* Diabetes mellitus.
* Dyslipidemia (total cholesterol \>250 mg/dL or in lipid-lowering therapy).
* Clinically demonstrable neurological and/or neuropsychological disorders.
* Hormone replacement therapy.
* Allergy and/or intolerance to cocoa or any of the components of the supplement.
* Hypocaloric diet.
* Any other circumstance that the investigators consider could interfere with the study procedures.

Primary outcomes:
measure: Blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: Arterial stiffness
timeFrame: 6 months
measure: Wave reflection
timeFrame: 6 months
measure: Body composition
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Cognitive performance
timeFrame: 6 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Instituto Biosanitario de Salamanca. Research unit La Alamedilla
Study officials:
affiliation: University of Salamanca
name: Jose I Recio-Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Yu IA, Garcia-Ortiz L, Gomez-Marcos MA, Rodriguez-Sanchez E, Mora-Simon S, Maderuelo-Fernandez JA, Recio-Rodriguez JI. Effects of cocoa-rich chocolate on cognitive performance in postmenopausal women. A randomised clinical trial. Nutr Neurosci. 2022 Jun;25(6):1147-1158. doi: 10.1080/1028415X.2020.1840119. Epub 2020 Nov 15.
citation: Garcia-Yu IA, Garcia-Ortiz L, Gomez-Marcos MA, Alonso-Dominguez R, Gonzalez-Sanchez J, Mora-Simon S, Gonzalez-Manzano S, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Recio-Rodriguez JI. Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial. BMJ Open. 2018 Dec 14;8(12):e024095. doi: 10.1136/bmjopen-2018-024095.