Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population

June 17, 2013 updated by: Alfredo Martinez, Clinica Universidad de Navarra, Universidad de Navarra

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline and 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
Height
Time Frame: Baseline
Baseline
Change from baseline of body weight
Time Frame: Baseline and 2 weeks
Baseline and 2 weeks
Change from baseline of body weight
Time Frame: Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
Personality Test
Time Frame: Baseline
Personality will be evaluated through the NEO-PI-R test.
Baseline
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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
Baseline and 4 weeks
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.
Baseline and 4 weeks
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.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Navarra

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UNAV-006/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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