Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Effect of Ready-cooked Meals Containing Cocoa Extract, as a Potential Functional Ingredient, on Cardiovascular Risk Markers in Older Population

Conditions
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Cardiovascular Risk Factors

Intervention / Treatment
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* Dietary Supplement: Cocoa extract


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group, placebo<br>This period will consist on a structured personalised hypocaloric diet containing ready prepared meals without extract added | Dietary Supplement: Cocoa extract<br>* Participants will follow a hypocaloric diet during two periods of 4 weeks, each. Within these diets, participants will consume daily 2 ready prepared frozen meals containing cocoa extract (0.7 g per meal; 1.4g per day) or nothing (placebo).<br>* Other names: bioactive ingredients;|
| Experimental: Intervention group, cocoa extract<br>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. | Dietary Supplement: Cocoa extract<br>* Participants will follow a hypocaloric diet during two periods of 4 weeks, each. Within these diets, participants will consume daily 2 ready prepared frozen meals containing cocoa extract (0.7 g per meal; 1.4g per day) or nothing (placebo).<br>* Other names: bioactive ingredients;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Plasma Oxidized LDL | Levels of LDL-ox in plasma will be analysed at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of fat mass content | Fat mass will be measured by bioelectric impedance and Dual X-ray absorptiometry at baseline and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of waist circumference | Waist circumference will be measured with a measure tape at baseline and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of hip circumference | Hip circumference will be measured with a measure tape at baseline and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Height |  | Baseline | 
| Change from baseline of body weight |  | Baseline and 2 weeks | 
| Change from baseline of body weight |  | Baseline and 4 weeks | 
| Change from baseline of skinfolds | Tricipital, Bicipital, subscapular and suprailiac skinfolds will be measured at baseline and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of serum glucose levels | Serum glucose concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of serum insulin concentration | Serum insulin concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of serum free fatty acids concentration | Serum free fatty acids concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of serum total cholesterol concentration | Serum total cholesterol concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of serum HDL-cholesterol concentration | Serum HDL-cholesterol concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of serum LDL-cholesterol concentration | Serum LDL-cholesterol concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of serum triglycerides concentration | Serum triglycerides concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of serum total protein concentration | Serum total protein concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of serum transaminases concentration | Serum transaminases (AST & ALT) concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of serum homocystein concentration | Serum homocystein concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of Diastolic blood pressure | Diastolic blood pressure will be measured at baseline and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of Systolic blood pressure | Systolic blood pressure will be measured at baseline and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of Food intake | Food intake will be measured by a 72 h weighed food record at baseline and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of plasma PAI-1 concentration | Plasma PAI-1 concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of plasma malonyldialdehyde (MDA) concentration | Plasma MDA concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of plasma total antioxidant capacity (TAC) | Plasma TAC will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of serum uric acid levels | Serum uric acid levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of Glutathione peroxidase activity | Glutathione peroxidase activity will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of plasma C-Reactive Protein levels | C-Reactive Protein levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of plasma IL-6 levels | IL-6 levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of plasma TNF-alpha levels | TNF-alpha levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Personality Test | Personality will be evaluated through the NEO-PI-R test. | Baseline | 
| Change from baseline of depression degree | Depression degree will be evaluated through the Beck depression inventory, the anxiety/STAI inventory and subjective anxiety and depression thermometer scale, at the beginning and the end of each intervention period | Baseline and 4 weeks | 
| Change from baseline of health status | Health status will be evaluated through the SF-36v2 Health survey at the beginning and the end of each intervention period | Baseline and 4 weeks | 
| Change from baseline of plasma VCAM-1 levels | VCAM-1 levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Change from baseline of plasma ICAM-1 levels | ICAM-1 levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period | Baseline and 4 weeks | 
| Cocoa Bioavailability | Metabolites from cocoa polyphenols will be analysed in plasma and urine at the beginning and the end of each intervention period in order to estimate the bioavailability of cocoa extract studied. | Baseline and 4 weeks | 
| DNA damage | DNA ability to self-repair and DNA damage extent will be quantified through commet assay at the beginning and the end of each intervention period. | Baseline and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular risk, Elderly population, cocoa extract, overweight and obesity, Glycemic profile, lipid profile, antioxidant status, inflammatory state, Cardiovascular Risk factors in elder population