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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-08-31

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.

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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.

Conditions

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Postmenopausal Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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

Group Type EXPERIMENTAL

Intervention group

Intervention Type DIETARY_SUPPLEMENT

10 g/day of high cocoa content chocolate for six months.

Interventions

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Intervention group

10 g/day of high cocoa content chocolate for six months.

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes