Effect of Short-term Annatto Carotenoids Supplementation on Oxidative Stress Status in Healthy Individuals

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820245
• Other study ID #: 68801917.0.0000.5346
• Status: Completed
• Phase: N/A
• Start date: August 24, 2016
• Est. completion date: July 25, 2018

Study information

• Verified date: December 2019
• Source: Universidade Federal de Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 25, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Oxidative Stress

Intervention

Dietary Supplement:
• Bixin
Volunteers consumed bixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
• Norbixin
Volunteers consumed norbixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
• Lycopene
Volunteers consumed lycopene capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
• Placebo
Volunteers consumed placebo capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)

Locations

Country	Name	City	State
Brazil	Universidade Federal de Santa Maria	Santa Maria	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - oxidation rate	Change (Day 7 - Day 0) of oxidation rate of conjugated dienes formed after copper sulphate addition to LDL particles	Day 0 and Day 7
Primary	Evaluation of LDL protein moiety susceptibility to copper induced oxidation	Evaluate the change (Day 7 - Day 0) of loss of tryptophan fluorescence after oxidation induced by copper	Day 0 and Day 7
Primary	Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - lag phase	Change (Day 7 - Day 0) of lag phase time of conjugated dienes formed after copper sulphate addition to LDL particles	Day 0 and Day 7
Secondary	Evaluation of protein oxidation	Change at advanced oxidation protein products levels in plasma	Day 0 and Day 7
Secondary	Evaluation of lipid oxidation	Change at malondialdehyde levels in plasma and red blood cells	Day 0 and Day 7
Secondary	Evaluation of nitric oxide metabolites	Change at nitric oxide metabolites levels in serum	Day 0 and Day 7
Secondary	Evaluation of plasma antioxidant capacity	Change at oxygen radical absorbance capacity in plasma	Day 0 and Day 7
Secondary	Evaluation of enzymatic antioxidant defences	Change at antioxidant enzymes activities in red blood cells	Day 0 and Day 7
Secondary	Evaluation of gluthatione cycle	Change at reduced glutathione/oxidized glutathione ratio in red blood cells	Day 0 and Day 7
Secondary	Evaluation of red blood cell osmotic fragility	Change of red blood cell osmotic fragility after ex vivo exposure to membrane damage inducers	Day 7
Secondary	Evaluation of carotenoids levels	Change at carotenoids levels in plasma and red blood cells	Day 0 and Day 7