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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
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).
Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
Pamplona, Navarre, Spain
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
Time frame: Baseline and 4 weeks
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
Time frame: 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
Time frame: 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
Time frame: Baseline and 4 weeks
Height
Time frame: Baseline
Change from baseline of body weight
Time frame: Baseline and 2 weeks
Change from baseline of body weight
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 4 weeks
Personality Test
Personality will be evaluated through the NEO-PI-R test.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 4 weeks
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