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Completed

NCT Number: NCT03492983

Effect of High Cocoa Content Chocolate on Health 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.

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Key information

Age range

50 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Biosanitario de Salamanca. Research unit La Alamedilla

Salamanca, 37003, Spain

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention Group

Dietary Supplement

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

Primary outcomes

  1. Blood pressure

    Time frame: 6 months

    Measurement by oscillometric method (mmHg)

Secondary outcomes

  1. Arterial stiffness

    Time frame: 6 months

    Measurement by Brachial-ankle pulse wave velocity (m/s)

  2. Wave reflection

    Time frame: 6 months

    Measurement by central and peripheral augmentation index

  3. Body composition

    Time frame: 6 months

    Measurement by body fat percentage

  4. Quality of life

    Time frame: 6 months

    Measurement by Cervantes Scale (Score between 0 (poor quality) and 155 (high quality)

  5. Cognitive performance

    Time frame: 6 months

    Measurement by executive function

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Other

Collaborators

  • Castilla-León Health Service

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 10, 2018
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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