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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postmenopausal Women

Intervention / Treatment
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* Dietary Supplement: Intervention group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No intervention | |
| Experimental: Intervention group<br>Addition of 10 g/day of high cocoa content chocolate to the usual diet for six months | Dietary Supplement: Intervention group<br>* 10 g/day of high cocoa content chocolate for six months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Measurement by oscillometric method (mmHg) | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular function, Cocoa, Body composition, Quality of life, Cognitive performance, Postmenopausal women