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
  Purpose

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.


Condition Intervention
Cardiovascular Risk Factors
Dietary Supplement: Cocoa extract

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effect of Ready-cooked Meals Containing Cocoa Extract, as a Potential Functional Ingredient, on Cardiovascular Risk Markers in Older Population

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: control group, placebo
This period will consist on a structured personalised hypocaloric diet containing ready prepared meals without extract added
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
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.
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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596309

Locations
Spain
Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
University of Navarra
Investigators
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
  More Information

No publications provided by Clinica Universidad de Navarra, Universidad de Navarra

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alfredo Martinez, Professor of Nutrition and Bromatology, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01596309     History of Changes
Other Study ID Numbers: UNAV-006/2012
Study First Received: May 9, 2012
Last Updated: June 17, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
cardiovascular risk
Elderly population
cocoa extract
overweight and obesity
Glycemic profile
lipid profile
antioxidant status
inflammatory state
Cardiovascular Risk factors in elder population

ClinicalTrials.gov processed this record on July 26, 2014