Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population

NCT01596309 | Completed

• 1 other identifier: UNAV-006/2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (35)

• Change from baseline of fat mass content

  Baseline and 4 weeks

• Change from baseline of waist circumference

  Baseline and 4 weeks

• Change from baseline of hip circumference

  Baseline and 4 weeks

• Height

  Baseline

• Change from baseline of body weight

  Baseline and 2 weeks

Study Arms (2)

control group, placebo

PLACEBO COMPARATOR

This period will consist on a structured personalised hypocaloric diet containing ready prepared meals without extract added

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.

Dietary Supplement: Cocoa extract

Interventions

Cocoa extract DIETARY_SUPPLEMENT

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).

Also known as: Ready prepared meals, bioactive ingredients

Intervention group, cocoa extract; control group, placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• University of Navarra: collaborator

Study Sites (1)

Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (4)

• 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.

  PMID: 26962189 DERIVED

• 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.

  PMID: 25527736 DERIVED

• 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.

  PMID: 25434574 DERIVED

• 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.

  PMID: 24462367 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Chocolate; Fast Foods

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• J. Alfredo Martinez, PhD, RN

  University of Navarra, Pamplona, Spain

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition and Bromatology

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 10, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 18, 2013

Record last verified: 2012-09

Locations

ES (1)