Effect of Short-term Annatto Carotenoids Supplementation on Oxidative Stress Status in Healthy Individuals
Condition: Oxidative Stress; Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

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.
    

Intervention name(s): Bixin; Norbixin; Lycopene; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Volunteers consumed bixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol); Volunteers consumed norbixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol); Volunteers consumed lycopene capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol); Volunteers consumed placebo capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
Intervention MeSH terms: Lycopene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Carotenoid; LDL oxidation; Cardiovascular disease; Antioxidant