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

February 20, 2020 updated by: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain, 37003
        • Instituto Biosanitario de Salamanca. Research unit La Alamedilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Collaborators

Castilla-León Health Service

Investigators

  • Principal Investigator: Jose I Recio-Rodriguez, PhD, University of Salamanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GRS 1583/B/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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