Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population

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: Completed
• Conditions: Cardiovascular Risk Factors
• Intervention / Treatment: Dietary supplement: Cocoa extract

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Height		Baseline
Change from baseline of body weight		Baseline and 2 weeks
Change from baseline of body weight		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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Baseline and 4 weeks
Personality Test	Personality will be evaluated through the NEO-PI-R test.	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	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	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	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	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.	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.	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: 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

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Estimate): June 18, 2013
• Last Update Submitted That Met QC Criteria: June 17, 2013
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: cardiovascular risk; overweight and obesity; Elderly population; cocoa extract; Glycemic profile; lipid profile; antioxidant status; inflammatory state; Cardiovascular Risk factors in elder population
• Other Study ID Numbers: UNAV-006/2012