Effect of Short-term Annatto Carotenoids Supplementation on Oxidative Stress Status in Healthy Individuals
- Conditions
- Oxidative StressAtherosclerosis
- Interventions
- Dietary Supplement: BixinDietary Supplement: LycopeneDietary Supplement: PlaceboDietary Supplement: Norbixin
- Registration Number
- NCT03820245
- Lead Sponsor
- Universidade Federal de Santa Maria
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- Normal levels of glucose, lipid profile, transaminases, urea and creatine
- Normal blood pressure, weight and body mass index (BMI)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Bixin Bixin Consumption of 0.05 mg bixin/kg b.w. through capsules (once a day) by 7 days in the morning. Lycopene Lycopene Consumption of 0.05 mg lycopene/kg b.w. through capsules (once a day) by 7 days in the morning. Placebo Placebo Consumption of 0.05 mg placebo/kg b.w. through capsules (once a day) by 7 days in the morning. Norbixin Norbixin Consumption of 0.05 mg norbixin/kg b.w. through capsules (once a day) by 7 days in the morning.
- Primary Outcome Measures
Name Time Method Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - oxidation rate 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 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 Day 0 and Day 7 Evaluate the change (Day 7 - Day 0) of loss of tryptophan fluorescence after oxidation induced by copper
- Secondary Outcome Measures
Name Time Method Evaluation of red blood cell osmotic fragility Day 7 Change of red blood cell osmotic fragility after ex vivo exposure to membrane damage inducers
Evaluation of protein oxidation Day 0 and Day 7 Change at advanced oxidation protein products levels in plasma
Evaluation of lipid oxidation Day 0 and Day 7 Change at malondialdehyde levels in plasma and red blood cells
Evaluation of nitric oxide metabolites Day 0 and Day 7 Change at nitric oxide metabolites levels in serum
Evaluation of gluthatione cycle Day 0 and Day 7 Change at reduced glutathione/oxidized glutathione ratio in red blood cells
Evaluation of carotenoids levels Day 0 and Day 7 Change at carotenoids levels in plasma and red blood cells
Evaluation of plasma antioxidant capacity Day 0 and Day 7 Change at oxygen radical absorbance capacity in plasma
Evaluation of enzymatic antioxidant defences Day 0 and Day 7 Change at antioxidant enzymes activities in red blood cells
Trial Locations
- Locations (1)
Universidade Federal de Santa Maria
🇧🇷Santa Maria, Rio Grande Do Sul, Brazil