Lipid Peroxidation Clinical Trial
Official title:
Protective Effects of Cocoa Ingestion Over Healthy Males Plasma Lipids Subjected to Peroxidative Conditions
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Status | Clinical Trial | Phase | |
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Completed |
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