Universidade Federal de Santa Maria
Santa Maria, Rio Grande do Sul, Brazil
NCT Number: NCT03820245
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.
Looking for future studies?
Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Santa Maria, Rio Grande do Sul, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Day 0 and Day 7
Change (Day 7 - Day 0) of oxidation rate of conjugated dienes formed after copper sulphate addition to LDL particles
Time frame: Day 0 and Day 7
Evaluate the change (Day 7 - Day 0) of loss of tryptophan fluorescence after oxidation induced by copper
Time frame: 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
Time frame: Day 0 and Day 7
Change at advanced oxidation protein products levels in plasma
Time frame: Day 0 and Day 7
Change at malondialdehyde levels in plasma and red blood cells
Time frame: Day 0 and Day 7
Change at nitric oxide metabolites levels in serum
Time frame: Day 0 and Day 7
Change at oxygen radical absorbance capacity in plasma
Time frame: Day 0 and Day 7
Change at antioxidant enzymes activities in red blood cells
Time frame: Day 0 and Day 7
Change at reduced glutathione/oxidized glutathione ratio in red blood cells
Time frame: Day 7
Change of red blood cell osmotic fragility after ex vivo exposure to membrane damage inducers
Time frame: Day 0 and Day 7
Change at carotenoids levels in plasma and red blood cells
Universidade Federal de Santa Maria
Other
Short-term Annatto Carotenoids Supplementation Effect on LDL Susceptibility to Ex-vivo Oxidation and Oxidative Stress Biomarkers in Healthy Individuals
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00908297
Arterial Occlusive Diseases, Arteriosclerosis
Seattle, Washington, United States
View Trial DetailsNCT01967459
Arterial Occlusive Diseases, Arteriosclerosis
Rotterdam, South Holland, Netherlands
View Trial DetailsNCT01408680
Arterial Occlusive Diseases, Arteriosclerosis
Seattle, Washington, United States
View Trial DetailsNCT01013103
Arterial Occlusive Diseases, Arteriosclerosis
Athens, Attica, Greece
View Trial Details