Protective Effects of Cocoa Ingestion Over Healthy Males Plasma Lipids Subjected to Peroxidative Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Oxidative protection index
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal lipid profile
- •Age between 20 and 30 years old
- •Must like chocolate
排除标准
- •Diagnosed coronary artery disease
- •Diabetes mellitus
- •Hypertension
- •Use of any prescribed medication
- •Restrictive diets and any
- •Migraine or
- •Cocoa products allergic antecedents
结局指标
主要结局
Oxidative protection index
时间窗: 7-days after the intervention started.
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
次要结局
- Oxidation resistance index (ORI)(7-days after the intervention started)