Clinical trial NCT01347450: Protective Effects of Cocoa Ingestion Over Healthy Males Plasma Lipids Subjected to Peroxidative Conditions
Official title: Protective Effects of Cocoa Ingestion Over Healthy Males Plasma Lipids Subjected to Peroxidative Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Peroxidation
Keywords: Flavonoids
cacao
lipid peroxidation
plasma
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
First posted: 2011-05-04
Enrollment: 136
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Oxidative protection index
timeFrame: 7-days after the intervention started.
Secondary outcomes:
measure: Oxidation resistance index (ORI)
timeFrame: 7-days after the intervention started
Other outcomes:
Locations:
city: Bogotá DC.
country: Colombia
facility: Fundación Santa Fe de Bogotá, Universidad Industrial de Santander.
Study officials:
affiliation: Fundación Santa Fe de Bogotá
name: Gabriel Carrasquilla, PhD
role: STUDY_DIRECTOR
References:
citation: 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.