Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population

This study has been completed.
Sponsor:
Collaborator:
University of Navarra
Information provided by (Responsible Party):
Alfredo Martinez, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01596309
First received: May 9, 2012
Last updated: June 17, 2013
Last verified: September 2012

May 9, 2012
June 17, 2013
January 2012
July 2012   (final data collection date for primary outcome measure)
Change from baseline of Plasma Oxidized LDL [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
Levels of LDL-ox in plasma will be analysed at the beginning and the end (4 weeks) of each intervention period
Same as current
Complete list of historical versions of study NCT01596309 on ClinicalTrials.gov Archive Site
  • Change from baseline of fat mass content [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Hip circumference will be measured with a measure tape at baseline and the end (4 weeks) of each intervention period
  • Height [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change from baseline of body weight [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
  • Change from baseline of body weight [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline of skinfolds [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Personality will be evaluated through the NEO-PI-R test.
  • Change from baseline of depression degree [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population
Study of the Effect of Ready-cooked Meals Containing Cocoa Extract, as a Potential Functional Ingredient, on Cardiovascular Risk Markers 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Cardiovascular Risk Factors
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).
Other Names:
  • Ready prepared meals
  • bioactive ingredients
  • Placebo Comparator: control group, placebo
    This period will consist on a structured personalised hypocaloric diet containing ready prepared meals without extract added
    Intervention: Dietary Supplement: Cocoa extract
  • 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.
    Intervention: Dietary Supplement: Cocoa extract
Ibero-Baraibar I, Abete I, Navas-Carretero S, Massis-Zaid A, Martinez JA, Zulet MA. Oxidised LDL levels decreases after the consumption of ready-to-eat meals supplemented with cocoa extract within a hypocaloric diet. Nutr Metab Cardiovasc Dis. 2014 Apr;24(4):416-22. doi: 10.1016/j.numecd.2013.09.017. Epub 2013 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2012
July 2012   (final data collection date for primary outcome measure)

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)
Both
50 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01596309
UNAV-006/2012
No
Alfredo Martinez, Clinica Universidad de Navarra, Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
University of Navarra
Principal Investigator: J. Alfredo Martinez, PhD, RN University of Navarra, Pamplona, Spain
Study Chair: M. Angeles Zulet, PhD University of Navarra, Pamplona, Spain
Study Chair: Santiago Navas-Carretero, PhD University of Navarra, Pamplona, Spain
Study Chair: Idoia Ibero, M. Sc University of Navarra, Pamplona, Spain
Clinica Universidad de Navarra, Universidad de Navarra
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP