Clinical trial NCT01596309: Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Keywords: cardiovascular risk
Elderly population
cocoa extract
overweight and obesity
Glycemic profile
lipid profile
antioxidant status
inflammatory state
Cardiovascular Risk factors in elder population
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: University of Navarra
First posted: 2012-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility 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)

Primary outcomes:
measure: Change from baseline of Plasma Oxidized LDL
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change from baseline of fat mass content
timeFrame: Baseline and 4 weeks
measure: Change from baseline of waist circumference
timeFrame: Baseline and 4 weeks
measure: Change from baseline of hip circumference
timeFrame: Baseline and 4 weeks
measure: Height
timeFrame: Baseline
measure: Change from baseline of body weight
timeFrame: Baseline and 2 weeks
measure: Change from baseline of body weight
timeFrame: Baseline and 4 weeks
measure: Change from baseline of skinfolds
timeFrame: Baseline and 4 weeks
measure: Change from baseline of serum glucose levels
timeFrame: Baseline and 4 weeks
measure: Change from baseline of serum insulin concentration
timeFrame: Baseline and 4 weeks
measure: Change from baseline of serum free fatty acids concentration
timeFrame: Baseline and 4 weeks
measure: Change from baseline of serum total cholesterol concentration
timeFrame: Baseline and 4 weeks
measure: Change from baseline of serum HDL-cholesterol concentration
timeFrame: Baseline and 4 weeks
measure: Change from baseline of serum LDL-cholesterol concentration
timeFrame: Baseline and 4 weeks
measure: Change from baseline of serum triglycerides concentration
timeFrame: Baseline and 4 weeks
measure: Change from baseline of serum total protein concentration
timeFrame: Baseline and 4 weeks
measure: Change from baseline of serum transaminases concentration
timeFrame: Baseline and 4 weeks
measure: Change from baseline of serum homocystein concentration
timeFrame: Baseline and 4 weeks
measure: Change from baseline of Diastolic blood pressure
timeFrame: Baseline and 4 weeks
measure: Change from baseline of Systolic blood pressure
timeFrame: Baseline and 4 weeks
measure: Change from baseline of Food intake
timeFrame: Baseline and 4 weeks
measure: Change from baseline of plasma PAI-1 concentration
timeFrame: Baseline and 4 weeks
measure: Change from baseline of plasma malonyldialdehyde (MDA) concentration
timeFrame: Baseline and 4 weeks
measure: Change from baseline of plasma total antioxidant capacity (TAC)
timeFrame: Baseline and 4 weeks
measure: Change from baseline of serum uric acid levels
timeFrame: Baseline and 4 weeks
measure: Change from baseline of Glutathione peroxidase activity
timeFrame: Baseline and 4 weeks
measure: Change from baseline of plasma C-Reactive Protein levels
timeFrame: Baseline and 4 weeks
measure: Change from baseline of plasma IL-6 levels
timeFrame: Baseline and 4 weeks
measure: Change from baseline of plasma TNF-alpha levels
timeFrame: Baseline and 4 weeks
measure: Personality Test
timeFrame: Baseline
measure: Change from baseline of depression degree
timeFrame: Baseline and 4 weeks
measure: Change from baseline of health status
timeFrame: Baseline and 4 weeks
measure: Change from baseline of plasma VCAM-1 levels
timeFrame: Baseline and 4 weeks
measure: Change from baseline of plasma ICAM-1 levels
timeFrame: Baseline and 4 weeks
measure: Cocoa Bioavailability
timeFrame: Baseline and 4 weeks
measure: DNA damage
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
state: Navarra
Study officials:
affiliation: University of Navarra, Pamplona, Spain
name: J. Alfredo Martinez, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Navarra, Pamplona, Spain
name: M. Angeles Zulet, PhD
role: STUDY_CHAIR
affiliation: University of Navarra, Pamplona, Spain
name: Santiago Navas-Carretero, PhD
role: STUDY_CHAIR
affiliation: University of Navarra, Pamplona, Spain
name: Idoia Ibero, M. Sc
role: STUDY_CHAIR
References:
citation: 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.
citation: Ibero-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.
citation: Ibero-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.
citation: 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.