Postmenopausal Women
Conditions
Keywords
Cocoa, Vascular function, Body composition, Quality of life, Cognitive performance, Postmenopausal women
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.
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.
Interventions
DIETARY_SUPPLEMENTIntervention group
10 g/day of high cocoa content chocolate for six months.
Sponsors
Castilla-León Health Service
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 6 months | Measurement by oscillometric method (mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed