Effect of High Cocoa Content Chocolate on Health in Postmenopausal Women.

Not Applicable

Completed

• Conditions: Postmenopausal Women
• Interventions: Dietary Supplement: Intervention group

• Registration Number: NCT03492983
• Lead Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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.

Study Timeline

• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-10
• Study Start: 2018-06-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Intervention group	Addition of 10 g/day of high cocoa content chocolate to the usual diet for six months

Primary Outcome Measures

Name	Time	Method
Blood pressure	6 months	Measurement by oscillometric method (mmHg)

Secondary Outcome Measures

Name	Time	Method
Arterial stiffness	6 months	Measurement by Brachial-ankle pulse wave velocity (m/s)
Wave reflection	6 months	Measurement by central and peripheral augmentation index
Body composition	6 months	Measurement by body fat percentage
Quality of life	6 months	Measurement by Cervantes Scale (Score between 0 (poor quality) and 155 (high quality)
Cognitive performance	6 months	Measurement by executive function

Trial Locations

Locations (1)

Instituto Biosanitario de Salamanca. Research unit La Alamedilla; 🇪🇸 Salamanca, Spain