Cardiovascular Risk Factors
Conditions
Keywords
cardiovascular risk, Elderly population, cocoa extract, overweight and obesity, Glycemic profile, lipid profile, antioxidant status, inflammatory state, Cardiovascular Risk factors in elder population
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCocoa extract
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).
Sponsors
University of Navarra
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of Plasma Oxidized LDL | Baseline and 4 weeks | Levels of LDL-ox in plasma will be analysed at the beginning and the end (4 weeks) of each intervention period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of fat mass content | Baseline and 4 weeks | Fat mass will be measured by bioelectric impedance and Dual X-ray absorptiometry at baseline and the end (4 weeks) of each intervention period |
| Change from baseline of waist circumference | Baseline and 4 weeks | Waist circumference will be measured with a measure tape at baseline and the end (4 weeks) of each intervention period |
| Change from baseline of hip circumference | Baseline and 4 weeks | Hip circumference will be measured with a measure tape at baseline and the end (4 weeks) of each intervention period |
| Height | Baseline | — |
| Change from baseline of body weight | Baseline and 2 weeks | — |
| Change from baseline of skinfolds | Baseline and 4 weeks | Tricipital, Bicipital, subscapular and suprailiac skinfolds will be measured at baseline and the end (4 weeks) of each intervention period |
| Change from baseline of serum glucose levels | Baseline and 4 weeks | Serum glucose concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of serum insulin concentration | Baseline and 4 weeks | Serum insulin concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of serum free fatty acids concentration | Baseline and 4 weeks | Serum free fatty acids concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of serum total cholesterol concentration | Baseline and 4 weeks | Serum total cholesterol concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of serum HDL-cholesterol concentration | Baseline and 4 weeks | Serum HDL-cholesterol concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of serum LDL-cholesterol concentration | Baseline and 4 weeks | Serum LDL-cholesterol concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of serum total protein concentration | Baseline and 4 weeks | Serum total protein concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of serum transaminases concentration | Baseline and 4 weeks | Serum transaminases (AST & ALT) concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of serum homocystein concentration | Baseline and 4 weeks | Serum homocystein concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of Diastolic blood pressure | Baseline and 4 weeks | Diastolic blood pressure will be measured at baseline and the end (4 weeks) of each intervention period |
| Change from baseline of serum triglycerides concentration | Baseline and 4 weeks | Serum triglycerides concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of Food intake | Baseline and 4 weeks | Food intake will be measured by a 72 h weighed food record at baseline and the end (4 weeks) of each intervention period |
| Change from baseline of plasma PAI-1 concentration | Baseline and 4 weeks | Plasma PAI-1 concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of plasma malonyldialdehyde (MDA) concentration | Baseline and 4 weeks | Plasma MDA concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of plasma total antioxidant capacity (TAC) | Baseline and 4 weeks | Plasma TAC will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of serum uric acid levels | Baseline and 4 weeks | Serum uric acid levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of Glutathione peroxidase activity | Baseline and 4 weeks | Glutathione peroxidase activity will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of plasma C-Reactive Protein levels | Baseline and 4 weeks | C-Reactive Protein levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of plasma IL-6 levels | Baseline and 4 weeks | IL-6 levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of plasma TNF-alpha levels | Baseline and 4 weeks | TNF-alpha levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Personality Test | Baseline | Personality will be evaluated through the NEO-PI-R test. |
| Change from baseline of depression degree | Baseline and 4 weeks | 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 |
| Change from baseline of health status | Baseline and 4 weeks | Health status will be evaluated through the SF-36v2 Health survey at the beginning and the end of each intervention period |
| Change from baseline of plasma VCAM-1 levels | Baseline and 4 weeks | VCAM-1 levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Change from baseline of plasma ICAM-1 levels | Baseline and 4 weeks | ICAM-1 levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period |
| Cocoa Bioavailability | Baseline and 4 weeks | 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. |
| DNA damage | Baseline and 4 weeks | 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. |
| Change from baseline of Systolic blood pressure | Baseline and 4 weeks | Systolic blood pressure will be measured at baseline and the end (4 weeks) of each intervention period |
Countries
Spain
Outcome results
None listed