Cardiovascular Risk FactorsNCT01596309
Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population
A study testing Cocoa extract in people with Cardiovascular Risk Factors, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Cocoa extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
Pamplona, Navarre, 31008
About this study
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
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.
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Cocoa extract
- Keywords
- cardiovascular risk, Elderly population, cocoa extract, overweight and obesity, Glycemic profile, lipid profile, antioxidant status, inflammatory state, Cardiovascular Risk factors in elder population
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa extractDietary supplement
Also called Ready prepared meals, bioactive ingredients
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).
| Study group | Role | What they receive |
|---|---|---|
| control group, placebo | Placebo comparator | This period will consist on a structured personalised hypocaloric diet containing ready prepared meals without extract added Receives: Dietary Supplement: Cocoa extract |
| Intervention group, cocoa extract | Experimental | 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. Receives: Dietary Supplement: Cocoa extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Plasma Oxidized LDL
Levels of LDL-ox in plasma will be analysed at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Secondary outcomes (35)
Change from baseline of fat mass content
Fat mass will be measured by bioelectric impedance and Dual X-ray absorptiometry at baseline and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of waist circumference
Waist circumference will be measured with a measure tape at baseline and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of hip circumference
Hip circumference will be measured with a measure tape at baseline and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Height
Measured: Baseline
Change from baseline of body weight
Measured: Baseline and 2 weeks
Change from baseline of body weight
Measured: Baseline and 4 weeks
Change from baseline of skinfolds
Tricipital, Bicipital, subscapular and suprailiac skinfolds will be measured at baseline and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of serum glucose levels
Serum glucose concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of serum insulin concentration
Serum insulin concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of serum free fatty acids concentration
Serum free fatty acids concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of serum total cholesterol concentration
Serum total cholesterol concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of serum HDL-cholesterol concentration
Serum HDL-cholesterol concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of serum LDL-cholesterol concentration
Serum LDL-cholesterol concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of serum triglycerides concentration
Serum triglycerides concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of serum total protein concentration
Serum total protein concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of serum transaminases concentration
Serum transaminases (AST \& ALT) concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of serum homocystein concentration
Serum homocystein concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of Diastolic blood pressure
Diastolic blood pressure will be measured at baseline and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of Systolic blood pressure
Systolic blood pressure will be measured at baseline and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of Food intake
Food intake will be measured by a 72 h weighed food record at baseline and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of plasma PAI-1 concentration
Plasma PAI-1 concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of plasma malonyldialdehyde (MDA) concentration
Plasma MDA concentration will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of plasma total antioxidant capacity (TAC)
Plasma TAC will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of serum uric acid levels
Serum uric acid levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of Glutathione peroxidase activity
Glutathione peroxidase activity will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of plasma C-Reactive Protein levels
C-Reactive Protein levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of plasma IL-6 levels
IL-6 levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of plasma TNF-alpha levels
TNF-alpha levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Personality Test
Personality will be evaluated through the NEO-PI-R test.
Measured: Baseline
Change from baseline of depression degree
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
Measured: Baseline and 4 weeks
Change from baseline of health status
Health status will be evaluated through the SF-36v2 Health survey at the beginning and the end of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of plasma VCAM-1 levels
VCAM-1 levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Change from baseline of plasma ICAM-1 levels
ICAM-1 levels will be measured in a fasting state at the beginning and the end (4 weeks) of each intervention period
Measured: Baseline and 4 weeks
Cocoa Bioavailability
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.
Measured: Baseline and 4 weeks
DNA damage
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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarra
- Responsible party
- Principal investigator, Alfredo Martinez, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- J. Alfredo Martinez, PhD, RN, Principal investigator, University of Navarra, Pamplona, SpainM. Angeles Zulet, PhD, Study chair, University of Navarra, Pamplona, SpainSantiago Navas-Carretero, PhD, Study chair, University of Navarra, Pamplona, SpainIdoia Ibero, M. Sc, Study chair, University of Navarra, Pamplona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596309
- Sponsor's protocol ID
- UNAV-006/2012
- Status last verified
- Sep 2012
- First submitted
- 9 May 2012
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ibero-Baraibar I, Perez-Cornago A, Ramirez MJ, Martinez JA, Zulet MA. An Increase in Plasma Homovanillic Acid with Cocoa Extract Consumption Is Associated with the Alleviation of Depressive Symptoms in Overweight or Obese Adults on an Energy Restricted Diet in a Randomized Controlled Trial. J Nutr. 2015 Apr 1;146(4):897S-904S. doi: 10.3945/jn.115.222828.
PubMed 26962189Ibero-Baraibar I, Azqueta A, Lopez de Cerain A, Martinez JA, Zulet MA. Assessment of DNA damage using comet assay in middle-aged overweight/obese subjects after following a hypocaloric diet supplemented with cocoa extract. Mutagenesis. 2015 Jan;30(1):139-46. doi: 10.1093/mutage/geu056.
PubMed 25527736Ibero-Baraibar I, Navas-Carretero S, Abete I, Martinez JA, Zulet MA. Increases in plasma 25(OH)D levels are related to improvements in body composition and blood pressure in middle-aged subjects after a weight loss intervention: Longitudinal study. Clin Nutr. 2015 Oct;34(5):1010-7. doi: 10.1016/j.clnu.2014.11.004. Epub 2014 Nov 11.
PubMed 25434574Ibero-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.
PubMed 24462367
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01596309
- Acronym / sponsor ID
- UNAV-006/2012
- Conditions
- Cardiovascular Risk Factors
- Keywords
- cardiovascular risk, Elderly population, cocoa extract, overweight and obesity, Glycemic profile, lipid profile, antioxidant status, inflammatory state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- University of Navarra
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group, placebo | Placebo comparator | Dietary Supplement: Cocoa extractThis period will consist on a structured personalised hypocaloric diet containing ready prepared meals without extract added |
| Intervention group, cocoa extract | Experimental | Dietary Supplement: Cocoa extractThis 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocoa extractAlso: Ready prepared meals, bioactive ingredientsParticipants 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). | Dietary supplement | Intervention group, cocoa extract, control group, placebo |
Primary outcome
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
35 secondary outcomes
Change from baseline of fat mass content
Time frame: Baseline and 4 weeks
Change from baseline of waist circumference
Time frame: Baseline and 4 weeks
Change from baseline of hip circumference
Time frame: Baseline and 4 weeks
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
Change from baseline of serum glucose levels
Time frame: Baseline and 4 weeks
Change from baseline of serum insulin concentration
Time frame: Baseline and 4 weeks
Change from baseline of serum free fatty acids concentration
Time frame: Baseline and 4 weeks
Change from baseline of serum total cholesterol concentration
Time frame: Baseline and 4 weeks
Change from baseline of serum HDL-cholesterol concentration
Time frame: Baseline and 4 weeks
Change from baseline of serum LDL-cholesterol concentration
Time frame: Baseline and 4 weeks
Change from baseline of serum triglycerides concentration
Time frame: Baseline and 4 weeks
Change from baseline of serum total protein concentration
Time frame: Baseline and 4 weeks
Change from baseline of serum transaminases concentration
Time frame: Baseline and 4 weeks
Change from baseline of serum homocystein concentration
Time frame: Baseline and 4 weeks
Change from baseline of Diastolic blood pressure
Time frame: Baseline and 4 weeks
Change from baseline of Systolic blood pressure
Time frame: Baseline and 4 weeks
Change from baseline of Food intake
Time frame: Baseline and 4 weeks
Change from baseline of plasma PAI-1 concentration
Time frame: Baseline and 4 weeks
Change from baseline of plasma malonyldialdehyde (MDA) concentration
Time frame: Baseline and 4 weeks
Change from baseline of plasma total antioxidant capacity (TAC)
Time frame: Baseline and 4 weeks
Change from baseline of serum uric acid levels
Time frame: Baseline and 4 weeks
Change from baseline of Glutathione peroxidase activity
Time frame: Baseline and 4 weeks
Change from baseline of plasma C-Reactive Protein levels
Time frame: Baseline and 4 weeks
Change from baseline of plasma IL-6 levels
Time frame: Baseline and 4 weeks
Change from baseline of plasma TNF-alpha levels
Time frame: Baseline and 4 weeks
Personality Test
Time frame: Baseline
Change from baseline of depression degree
Time frame: Baseline and 4 weeks
Change from baseline of health status
Time frame: Baseline and 4 weeks
Change from baseline of plasma VCAM-1 levels
Time frame: Baseline and 4 weeks
Change from baseline of plasma ICAM-1 levels
Time frame: Baseline and 4 weeks
Cocoa Bioavailability
Time frame: Baseline and 4 weeks
DNA damage
Time frame: Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
- Derived from this study: PubMed 26962189Ibero-Baraibar I, Perez-Cornago A, Ramirez MJ, Martinez JA, Zulet MA. An Increase in Plasma Homovanillic Acid with Cocoa Extract Consumption Is Associated with the Alleviation of Depressive Symptoms in Overweight or Obese Adults on an Energy Restricted Diet in a Randomized Controlled Trial. J Nutr. 2015 Apr 1;146(4):897S-904S. doi: 10.3945/jn.115.222828.
- Derived from this study: PubMed 25527736Ibero-Baraibar I, Azqueta A, Lopez de Cerain A, Martinez JA, Zulet MA. Assessment of DNA damage using comet assay in middle-aged overweight/obese subjects after following a hypocaloric diet supplemented with cocoa extract. Mutagenesis. 2015 Jan;30(1):139-46. doi: 10.1093/mutage/geu056.
- Derived from this study: PubMed 25434574Ibero-Baraibar I, Navas-Carretero S, Abete I, Martinez JA, Zulet MA. Increases in plasma 25(OH)D levels are related to improvements in body composition and blood pressure in middle-aged subjects after a weight loss intervention: Longitudinal study. Clin Nutr. 2015 Oct;34(5):1010-7. doi: 10.1016/j.clnu.2014.11.004. Epub 2014 Nov 11.
- Derived from this study: PubMed 24462367Ibero-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa extract in people with Cardiovascular Risk Factors, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of Plasma Oxidized LDL (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596309, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.