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

NCT ID: NCT01347450

Last Updated: 2011-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-08-31

Brief 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.

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

Conditions

Lipid Peroxidation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Cocoa, Placebo

Group Type: EXPERIMENTAL

Cocoa powder berverage, dark chocolate bar

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

OTHER_GOV

Sponsor Role: collaborator

Fundación Santa Fe de Bogota

OTHER

Sponsor Role: lead

Responsible Party

Fundación Santa Fe de Bogotá

Principal Investigators

Gabriel Carrasquilla, PhD

Role: STUDY_DIRECTOR

Fundación Santa Fe de Bogotá

Locations

Fundación Santa Fe de Bogotá, Universidad Industrial de Santander.

Bogotá DC., Bogotá DC., Colombia

Countries

Colombia

References

Barrios M, Orozco LC, Stashenko EE. Cocoa ingestion protects plasma lipids in healthy males against ex vivo oxidative conditions: A randomized clinical trial. Clin Nutr ESPEN. 2018 Aug;26:1-7. doi: 10.1016/j.clnesp.2018.05.001. Epub 2018 May 30.

Reference Type: DERIVED

PMID: 29908675 (View on PubMed)

Other Identifiers

20114

Identifier Type: -

Identifier Source: org_study_id