Clinical trial NCT03820245: Effect of Short-term Annatto Carotenoids Supplementation on Oxidative Stress Status in Healthy Individuals
Official title: Short-term Annatto Carotenoids Supplementation Effect on LDL Susceptibility to Ex-vivo Oxidation and Oxidative Stress Biomarkers in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Atherosclerosis
Keywords: Carotenoid
LDL oxidation
Cardiovascular disease
Antioxidant
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Normal levels of glucose, lipid profile, transaminases, urea and creatine
* Normal blood pressure, weight and body mass index (BMI)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - oxidation rate
timeFrame: Day 0 and Day 7
measure: Evaluation of LDL protein moiety susceptibility to copper induced oxidation
timeFrame: Day 0 and Day 7
measure: Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - lag phase
timeFrame: Day 0 and Day 7
Secondary outcomes:
measure: Evaluation of protein oxidation
timeFrame: Day 0 and Day 7
measure: Evaluation of lipid oxidation
timeFrame: Day 0 and Day 7
measure: Evaluation of nitric oxide metabolites
timeFrame: Day 0 and Day 7
measure: Evaluation of plasma antioxidant capacity
timeFrame: Day 0 and Day 7
measure: Evaluation of enzymatic antioxidant defences
timeFrame: Day 0 and Day 7
measure: Evaluation of gluthatione cycle
timeFrame: Day 0 and Day 7
measure: Evaluation of red blood cell osmotic fragility
timeFrame: Day 7
measure: Evaluation of carotenoids levels
timeFrame: Day 0 and Day 7
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Universidade Federal de Santa Maria
state: Rio Grande Do Sul
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Tatiana Emanuelli, Doctor
role: STUDY_DIRECTOR
References: