Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population

University of Navarra

Status: Completed

Conditions: Cardiovascular Risk Factors

Treatments: Dietary Supplement: Cocoa extract

Study type: Interventional

Funder types: Other

Identifiers

NCT01596309

UNAV-006/2012

Details and patient eligibility

About

Obesity prevalence in elderly populations has increased in the last years, and the reduction of overweight and obesity is a priority target in populations of all age ranges worldwide. Obesity is a disease frequently accompanied by a pro-inflammatory state, in which metabolic functions may be compromised, and therefore there is a risk of developing comorbidities such as type-2 diabetes, hyperlipidemias, hypertension, atherosclerosis, etc. In this context, plant extracts are a good source of antioxidant compounds. Among these compounds, polyphenols have been shown to have an important antioxidant effect. Scientific evidence based on epidemiological studies suggest that flavonoids from the diet play an important role on the prevention of cardiovascular disease. Cocoa and related products are an important source of flavonoids, providing even more than tea or wine. Generally, benefits associated to cocoa consumption are related to the ability for improving lipid profile and insulin sensitivity, reducing blood pressure, platelet activity and improving endothelial dysfunction. Some studies have also shown an improvement of inflammatory conditions, mainly due to the capacity of the polyphenols contained to modify cellular transcription, and the secretion of proinflammatory cytokines in peripheral blood mononuclear cells, macrophages and lymphocytic strains. Therefore, the hypothesis of this study is that the consumption of cocoa extract-enriched prepared meals, within a hypocaloric diet, will help to reduce body weight and to improve cardiovascular risk factors compared to the same diet with standard prepared meals.

Enrollment: 50 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index between 27 and 35.5 kg/m2
• Subjects with central adiposity (waist circumference over 94 cm in males and 80 cm in females)
• Subjects presenting insulin resistance non pharmacologically treated
• Subjects presenting hyperlipidemia non pharmacologically treated

Exclusion criteria

• Subjects following dietotherapy to loose weight at the moment of the study or in the past three months.
• Subjects with variations of weight greater than 5% of their body weight in the last three months).
• Subjects with deficient nutritional or hydration status.
• Subjects suffering from chronic diseases such as cancer, diabetes, hyperlipidemia, etc.
• Subjects with functional or structural impairments in digestive tract (peptic ulcer, malabsorption syndrome, inflammatory state, etc.)
• Subjects having gone under digestive surgery and have permanent consequences.
• Subjects suffering from allergy to cocoa or derived products.
• Subjects being physically or psychologically affected, with difficulties to attend the facilities with the required frequency.
• Smokers and frequent (more than 3 portions of beer/wine/spirits per day in males and 2 portions of beer/wine/spirits per day in females)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups, including a placebo group

control group, placebo

Placebo Comparator group

Description:

This period will consist on a structured personalised hypocaloric diet containing ready prepared meals without extract added

Treatment:

Dietary Supplement: Cocoa extract

Intervention group, cocoa extract

Experimental group

Description:

This period will consist on a structured personalised hypocaloric diet containing ready prepared meals with cocoa extract added. Final cocoa extract daily intake will be of 1.4 g.

Treatment:

Dietary Supplement: Cocoa extract