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Completed

NCT Number: NCT01596309

Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population

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.

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Key information

Conditions

Cardiovascular Risk Factors Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra

Pamplona, Navarre, 31008, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cocoa extract

Dietary Supplement

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).

Other names: Ready prepared meals, bioactive ingredients

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. Height

    Time frame: Baseline

  5. Change from baseline of body weight

    Time frame: Baseline and 2 weeks

  6. Change from baseline of body weight

    Time frame: Baseline and 4 weeks

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. Personality Test

    Time frame: Baseline

    Personality will be evaluated through the NEO-PI-R test.

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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.

  35. 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.

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • University of Navarra

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 10, 2012
Registry last updated
Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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