Effect of Short-term Annatto Carotenoids Supplementation on Oxidative Stress Status in Healthy Individuals
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ClinicalTrials.gov Identifier: NCT03820245 |
Recruitment Status :
Completed
First Posted : January 29, 2019
Last Update Posted : January 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Oxidative Stress Atherosclerosis | Dietary Supplement: Bixin Dietary Supplement: Norbixin Dietary Supplement: Lycopene Dietary Supplement: Placebo | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | Double blind |
Primary Purpose: | Prevention |
Official Title: | Short-term Annatto Carotenoids Supplementation Effect on LDL Susceptibility to Ex-vivo Oxidation and Oxidative Stress Biomarkers in Healthy Individuals |
Actual Study Start Date : | August 24, 2016 |
Actual Primary Completion Date : | April 15, 2018 |
Actual Study Completion Date : | July 25, 2018 |

Arm | Intervention/treatment |
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Experimental: Bixin
Consumption of 0.05 mg bixin/kg b.w. through capsules (once a day) by 7 days in the morning.
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Dietary Supplement: Bixin
Volunteers consumed bixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol) |
Experimental: Norbixin
Consumption of 0.05 mg norbixin/kg b.w. through capsules (once a day) by 7 days in the morning.
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Dietary Supplement: Norbixin
Volunteers consumed norbixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol) |
Active Comparator: Lycopene
Consumption of 0.05 mg lycopene/kg b.w. through capsules (once a day) by 7 days in the morning.
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Dietary Supplement: Lycopene
Volunteers consumed lycopene capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol) |
Placebo Comparator: Placebo
Consumption of 0.05 mg placebo/kg b.w. through capsules (once a day) by 7 days in the morning.
|
Dietary Supplement: Placebo
Volunteers consumed placebo capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol) |
- Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - oxidation rate [ 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
- Evaluation of LDL protein moiety susceptibility to copper induced oxidation [ Time Frame: Day 0 and Day 7 ]Evaluate the change (Day 7 - Day 0) of loss of tryptophan fluorescence after oxidation induced by copper
- Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - lag phase [ 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
- Evaluation of protein oxidation [ Time Frame: Day 0 and Day 7 ]Change at advanced oxidation protein products levels in plasma
- Evaluation of lipid oxidation [ Time Frame: Day 0 and Day 7 ]Change at malondialdehyde levels in plasma and red blood cells
- Evaluation of nitric oxide metabolites [ Time Frame: Day 0 and Day 7 ]Change at nitric oxide metabolites levels in serum
- Evaluation of plasma antioxidant capacity [ Time Frame: Day 0 and Day 7 ]Change at oxygen radical absorbance capacity in plasma
- Evaluation of enzymatic antioxidant defences [ Time Frame: Day 0 and Day 7 ]Change at antioxidant enzymes activities in red blood cells
- Evaluation of gluthatione cycle [ Time Frame: Day 0 and Day 7 ]Change at reduced glutathione/oxidized glutathione ratio in red blood cells
- Evaluation of red blood cell osmotic fragility [ Time Frame: Day 7 ]Change of red blood cell osmotic fragility after ex vivo exposure to membrane damage inducers
- Evaluation of carotenoids levels [ Time Frame: Day 0 and Day 7 ]Change at carotenoids levels in plasma and red blood cells

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820245
Brazil | |
Universidade Federal de Santa Maria | |
Santa Maria, Rio Grande Do Sul, Brazil |
Study Director: | Tatiana Emanuelli, Doctor | Universidade Federal de Santa Maria |
Responsible Party: | Lisiane Conte, Master's degree student, Universidade Federal de Santa Maria |
ClinicalTrials.gov Identifier: | NCT03820245 |
Other Study ID Numbers: |
68801917.0.0000.5346 |
First Posted: | January 29, 2019 Key Record Dates |
Last Update Posted: | January 2, 2020 |
Last Verified: | December 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Data may be shared after article publication. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Carotenoid LDL oxidation Cardiovascular disease Antioxidant |
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Lycopene Anti-Inflammatory Agents |
Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Radiation-Protective Agents Anticarcinogenic Agents Antineoplastic Agents |