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

Lipid Peroxidation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347450
• Other study ID #: 20114
• Status: Completed
• Phase: N/A
• First received: April 29, 2011
• Last updated: May 3, 2011
• Start date: October 2007
• Est. completion date: August 2008

Study information

• Verified date: September 2004
• Source: Fundación Santa Fe de Bogota
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Fundación Santa Fe de Bogotá
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lipid Peroxidation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	Fundación Santa Fe de Bogotá, Universidad Industrial de Santander.	Bogotá DC.

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Santa Fe de Bogota	Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative protection index	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	7-days after the intervention started.	No
Secondary	Oxidation resistance index (ORI)	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	7-days after the intervention started	No