Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population

Cardiovascular Risk Factors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596309
• Other study ID #: UNAV-006/2012
• Status: Completed
• Phase: N/A
• First received: May 9, 2012
• Last updated: June 17, 2013
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: September 2012
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Risk Factors

Intervention

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).

Locations

Country	Name	City	State
Spain	Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra	Pamplona	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	University of Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	Height		Baseline	No
Secondary	Change from baseline of body weight		Baseline and 2 weeks	No
Secondary	Change from baseline of body weight		Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	Change from baseline of Diastolic blood pressure	Diastolic blood pressure will be measured at baseline and the end (4 weeks) of each intervention period	Baseline and 4 weeks	No
Secondary	Change from baseline of Systolic blood pressure	Systolic blood pressure will be measured at baseline and the end (4 weeks) of each intervention period	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	Personality Test	Personality will be evaluated through the NEO-PI-R test.	Baseline	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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.	Baseline and 4 weeks	No
Secondary	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.	Baseline and 4 weeks	No