Short-term Annatto Carotenoids Supplementation Effect on LDL Susceptibility to Ex-vivo Oxidation and Oxidative Stress Biomarkers in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - oxidation rate
研究概览
简要总结
Low-density lipoprotein (LDL) oxidation has a pivotal role in atherosclerosis development. There is a relationship between carotenoids serum concentration and cardiovascular (CV) benefits, mainly in oxidized LDL (oxLDL) reduction. Despite cardio protective effects of annatto carotenoids, bixin and norbixin, in vitro and in animal studies, its short or long-term supplementation effect on humans are not know. Objective: To analyse CV benefits of annatto carotenoids short-term supplementation in healthy individuals, comparing to lycopene effect. Methods: 16 healthy volunteers (8 men and 8 women) consumed 0.05 mg/kg b.w. of each treatment (bixin, norbixin, lycopene or placebo) through capsules, during 7 days. It was analysed the susceptibility of LDL to Cu2+-induced oxidation, biochemical parameters and oxidative stress biomarkers at the beginning and end of each treatment.
详细描述
Graduate and post-graduate students were recruited in Federal University of Santa Maria to study participation. First, the health status of volunteers was analysed by questioner application (to evaluate lifestyle, family history, individual characteristics), anthropometric (height, weight, waist circumference) and biochemical parameters (glucose, lipid profile, transaminases, urea, creatinine) measurements. According to inclusion criteria, 18 volunteers were able to study participation, but just 16 people remained until the end of the study.
Each treatment was composed by 7 capsules (containing 0.05 mg carotenoid or placebo/kg b.w.) which should be consumed once a day (preferably in the morning), during 7 days. It was conducted a randomized, double blind, placebo-controlled crossover clinical trial, where 16 participants received 4 proposed treatments (bixin, norbixin, lycopene and placebo) in different periods. To plasma, serum and red blood cells (RBC) obtainment, 2 fasting blood collections were made, in the beginning (Day 0) and the end (Day 7) of each treatment. These samples were used for evaluating the ex vivo oxidation of LDL induced by copper sulphate and biochemical and oxidative biomarkers measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal levels of glucose, lipid profile, transaminases, urea and creatine
- •Normal blood pressure, weight and body mass index (BMI)
排除标准
- •Chronic diseases (diabetes, dyslipiademia, hypertension cancer, etc.)
- •Drug, alcohol and cigarette consumption/addiction
- •Medication, vitamins or suplements consumption (except oral contraceptive used by women)
- •Recent inflammatory/infectious diseases
结局指标
主要结局
Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - oxidation rate
时间窗: Day 0 and Day 7
Change (Day 7 - Day 0) of oxidation rate of conjugated dienes formed after copper sulphate addition to LDL particles
Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - lag phase
时间窗: Day 0 and Day 7
Change (Day 7 - Day 0) of lag phase time of conjugated dienes formed after copper sulphate addition to LDL particles
Evaluation of LDL protein moiety susceptibility to copper induced oxidation
时间窗: Day 0 and Day 7
Evaluate the change (Day 7 - Day 0) of loss of tryptophan fluorescence after oxidation induced by copper
次要结局
- Evaluation of protein oxidation(Day 0 and Day 7)
- Evaluation of red blood cell osmotic fragility(Day 7)
- Evaluation of lipid oxidation(Day 0 and Day 7)
- Evaluation of nitric oxide metabolites(Day 0 and Day 7)
- Evaluation of gluthatione cycle(Day 0 and Day 7)
- Evaluation of carotenoids levels(Day 0 and Day 7)
- Evaluation of plasma antioxidant capacity(Day 0 and Day 7)
- Evaluation of enzymatic antioxidant defences(Day 0 and Day 7)
研究者
Lisiane Conte
Master's degree student
Universidade Federal de Santa Maria
