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临床试验/NCT03820245
NCT03820245已完成不适用

Short-term Annatto Carotenoids Supplementation Effect on LDL Susceptibility to Ex-vivo Oxidation and Oxidative Stress Biomarkers in Healthy Individuals

Universidade Federal de Santa Maria1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年8月24日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisiane Conte

Master's degree student

Universidade Federal de Santa Maria

研究点 (1)

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