Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2012

Interventions

  • Dietary Supplement: Cocoa 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).

Arms, Groups and Cohorts

  • Placebo Comparator: control group, placebo
    • This period will consist on a structured personalised hypocaloric diet containing ready prepared meals without extract added
  • Experimental: Intervention group, cocoa extract
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline of Plasma Oxidized LDL
    • Time Frame: 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 Measures

  • Change from baseline of fat mass content
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 triglycerides concentration
    • Time Frame: 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 serum total protein concentration
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 Systolic blood pressure
    • Time Frame: Baseline and 4 weeks
    • Systolic blood pressure will be measured at baseline and the end (4 weeks) of each intervention period
  • Change from baseline of Food intake
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Baseline
    • Personality will be evaluated through the NEO-PI-R test.
  • Change from baseline of depression degree
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Clinica Universidad de Navarra, Universidad de Navarra
  • Collaborator
    • University of Navarra
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alfredo Martinez, Professor of Nutrition and Bromatology – Clinica Universidad de Navarra, Universidad de Navarra
  • Overall Official(s)
    • J. Alfredo Martinez, PhD, RN, Principal Investigator, University of Navarra, Pamplona, Spain
    • M. Angeles Zulet, PhD, Study Chair, University of Navarra, Pamplona, Spain
    • Santiago Navas-Carretero, PhD, Study Chair, University of Navarra, Pamplona, Spain
    • Idoia Ibero, M. Sc, Study Chair, University of Navarra, Pamplona, Spain

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