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

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Status: Completed

Conditions: Postmenopausal Women

Treatments: Dietary Supplement: Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT03492983

GRS 1583/B/17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 50 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Control group

No Intervention group

Description:

No intervention

Intervention group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Intervention group