Protective Effects of Cocoa Ingestion Over Healthy Males Plasma Lipids Subjected to Peroxidative Conditions

This study has been completed.
Sponsor:
Collaborator:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Information provided by:
Fundación Santa Fe de Bogota
ClinicalTrials.gov Identifier:
NCT01347450
First received: April 29, 2011
Last updated: May 3, 2011
Last verified: September 2004
  Purpose

Background: Cocoa is rich in flavonoids such as (-)-epicatechin and (+)-catechin; these compounds have displayed both in vitro and in vivo antioxidant activity.

Objective: This trial evaluate the regular ingestion effect of both, dark chocolate and cocoa powder, over plasma lipids of young males subjected to ex vivo lipid peroxidative conditions.

Design: Single-blind, controlled and randomized clinical trial including 100 healthy men, divided into two groups: 50 subjects received 30 g of cocoa powder and 50 g of dark chocolate/d for 1 wk, and the other 50 subjects received placebo.


Condition Intervention
Lipid Peroxidation
Dietary Supplement: Cocoa powder berverage, dark chocolate bar
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Protective Effects of Cocoa Ingestion Over Healthy Males Plasma Lipids Subjected to Peroxidative Conditions

Further study details as provided by Fundación Santa Fe de Bogota:

Primary Outcome Measures:
  • Oxidative protection index [ Time Frame: 7-days after the intervention started. ] [ Designated as safety issue: No ]
    Oxidative protection of plasma lipids was set up by measuring hexanal, known as one of the main components of oxidizing n-6 polyunsaturated fatty acids (PUFA). The oxidative protection index (OPI), was defined as the difference between the basal and post intervention (cocoa taking in) sample chromatographic areas as stated by the formula: OPI = (Area0 - Area1/ Area0)*100. Hexanal determination was carried out by HS-SPME in situ derivatization method using PFPH fibre saturation as derivatizing agent under the methodology


Secondary Outcome Measures:
  • Oxidation resistance index (ORI) [ Time Frame: 7-days after the intervention started ] [ Designated as safety issue: No ]
    ORI was expressed as a percentage and held as the difference among basal (0) and post interventions (1) lag time of each subject according to the following formula: ORI = (lag1 - lag0/ lag1)*100. Plasma was 50-fold diluted in a saline phosphate solution (PBS; 0.0027M KCl, 0.137M NaCl, pH 7.4) and then was exposed to copper (II) chloride at final concentration of 95 µM in a 2.5 ml quartz cuvette. Conjugated diene formation from lipid peroxidation was followed at 245 nm wavelength, recorded each 5 min over 4-h period at 37ºC in a Perkin Elmer Lambda Bio 10 spectrophotometer


Enrollment: 136
Study Start Date: October 2007
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cocoa, Placebo Dietary Supplement: Cocoa powder berverage, dark chocolate bar
Sugar drink containing 30 g of cocoa powder and 50 g of a 65% dark chocolate, and the control group received 30 g of placebo drink containing 0 g of cocoa powder. Each drink was prepared by using 300 ml of water and 30 g of sugar, also were consumed twice each day: with breakfast and afternoon meal. during 7-d after the intervention started.
Dietary Supplement: Placebo
Sugar drink containing 30 g of cocoa powder and 50 g of a 65% dark chocolate, and the control group received 30 g of placebo drink containing 0 g of cocoa powder. Each drink was prepared by using 300 ml of water and 30 g of sugar, also were consumed twice each day: with breakfast and afternoon meal. during 7-d after the intervention started.

Detailed Description:

Adult young males were enrolled at the Universidad Industrial de Santander by publicity at the university food service centre. Those who respond (n=136) were selected after the normal blood lipid profile was verified by laboratory testing of total cholesterol, LDL, HDL, VLDL and triacylglycerols, as well exclusion and inclusion criteria were applied. Within the exclusion criteria we included diagnosed coronary artery disease, diabetes mellitus, arterial hypertension, use of any prescribed medication, restrictive diets and any migraine or cocoa products allergic antecedents.

Finally enlisted subjects were 120 non-smokers, normolipemic, ages were between 20 and 30 years old, who underwent anthropometric measurements like weight, height, BMI (among 16.0 and 27.4 kg/m2) and regular nutritional and toxicological habits using standardized surveys. Subjects received 3 meals a day from the Food Nutritional Service of Universidad Industrial de Santander, in order to ensure the same diet conditions for all subjects along the experimental period. An average colombian diet, based on 2287 calories as a total caloric value (protein 15%, fats 35% and carbohydrates 60%) was used. The study protocol and the informed consent were approved by the Fundación Santa Fe de Bogotá Institutional Ethical Committee (Santa Fe de Bogotá D.C., Colombia). We got written informed consent from all participants and they received money compensation for its participation in the study.

Outcome measures:

Susceptibility of plasma lipids to oxidation Determination of plasma lipids oxidation resistance Determination of oxidative protection

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal lipid profile
  • Age between 20 and 30 years old
  • Must like chocolate

Exclusion Criteria:

  • Diagnosed coronary artery disease
  • Diabetes mellitus
  • Hypertension
  • Use of any prescribed medication
  • Restrictive diets and any
  • Migraine or
  • Cocoa products allergic antecedents
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01347450

Locations
Colombia
Fundación Santa Fe de Bogotá, Universidad Industrial de Santander.
Bogotá DC., Colombia
Sponsors and Collaborators
Fundación Santa Fe de Bogota
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Investigators
Study Director: Gabriel Carrasquilla, PhD Fundación Santa Fe de Bogotá
  More Information

No publications provided

Responsible Party: Manuel Barrios, Fundación Santa Fe de Bogotá
ClinicalTrials.gov Identifier: NCT01347450     History of Changes
Other Study ID Numbers: 20114
Study First Received: April 29, 2011
Last Updated: May 3, 2011
Health Authority: Colombia: Fundación Santa Fe de Bogotá

Keywords provided by Fundación Santa Fe de Bogota:
Flavonoids
cacao
lipid peroxidation
plasma

ClinicalTrials.gov processed this record on September 11, 2014