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

Sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud (Other)

Overall Status

Completed

CT.gov ID

NCT03492983

Collaborator

Castilla-León Health Service (Other)

140

Enrollment

Location

Arms

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Women	Dietary Supplement: Intervention group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Aug 31, 2019

Actual Study Completion Date :

Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group No intervention
Experimental: Intervention group Addition of 10 g/day of high cocoa content chocolate to the usual diet for six months	Dietary Supplement: Intervention group 10 g/day of high cocoa content chocolate for six months.

Arm

Intervention/Treatment

No Intervention: Control group

No intervention

Experimental: Intervention group

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

Dietary Supplement: Intervention group

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

Outcome Measures

Primary Outcome Measures

Blood pressure [6 months]
Measurement by oscillometric method (mmHg)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.