NCT01347450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
Last Updated

May 4, 2011

Status Verified

September 1, 2004

Enrollment Period

9 months

First QC Date

April 29, 2011

Last Update Submit

May 3, 2011

Conditions

Lipid Peroxidation

Keywords

Flavonoidscacaolipid peroxidationplasma

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Oxidation resistance index (ORI)

    7-days after the intervention started

Study Arms (1)

Cocoa, Placebo

EXPERIMENTAL
Dietary Supplement: Cocoa powder berverage, dark chocolate barDietary Supplement: Placebo

Interventions

Cocoa powder berverage, dark chocolate barDIETARY_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.

Cocoa, Placebo
PlaceboDIETARY_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.

Cocoa, Placebo

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Diagnosed coronary artery disease
  • Diabetes mellitus
  • Hypertension
  • Use of any prescribed medication
  • Restrictive diets and any
  • Migraine or
  • Cocoa products allergic antecedents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Santa Fe de Bogotá, Universidad Industrial de Santander.

Bogotá DC., Bogotá DC., Colombia

Location

Related Publications (1)

  • 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.

    PMID: 29908675DERIVED

Study Officials

  • Gabriel Carrasquilla, PhD

    Fundación Santa Fe de Bogotá

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2011

First Posted

May 4, 2011

Study Start

October 1, 2007

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

May 4, 2011

Record last verified: 2004-09

Locations

CO(1)