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

Postmenopausal Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492983
• Other study ID #: GRS 1583/B/17
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: February 2020
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postmenopausal Women

Intervention

Dietary Supplement:
• Intervention group
10 g/day of high cocoa content chocolate for six months.

Locations

Country	Name	City	State
Spain	Instituto Biosanitario de Salamanca. Research unit La Alamedilla	Salamanca

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud	Castilla-León Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Measurement by oscillometric method (mmHg)	6 months
Secondary	Arterial stiffness	Measurement by Brachial-ankle pulse wave velocity (m/s)	6 months
Secondary	Wave reflection	Measurement by central and peripheral augmentation index	6 months
Secondary	Body composition	Measurement by body fat percentage	6 months
Secondary	Quality of life	Measurement by Cervantes Scale (Score between 0 (poor quality) and 155 (high quality)	6 months
Secondary	Cognitive performance	Measurement by executive function	6 months