Effect of Short-term Annatto Carotenoids Supplementation on Oxidative Stress Status in Healthy Individuals
Primary Purpose
Oxidative Stress, Atherosclerosis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bixin
Norbixin
Lycopene
Placebo
Sponsored by

About this trial
This is an interventional prevention trial for Oxidative Stress focused on measuring Carotenoid, LDL oxidation, Cardiovascular disease, Antioxidant
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
Sites / Locations
- Universidade Federal de Santa Maria
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Bixin
Norbixin
Lycopene
Placebo
Arm Description
Consumption of 0.05 mg bixin/kg b.w. through capsules (once a day) by 7 days in the morning.
Consumption of 0.05 mg norbixin/kg b.w. through capsules (once a day) by 7 days in the morning.
Consumption of 0.05 mg lycopene/kg b.w. through capsules (once a day) by 7 days in the morning.
Consumption of 0.05 mg placebo/kg b.w. through capsules (once a day) by 7 days in the morning.
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Evaluation of protein oxidation
Change at advanced oxidation protein products levels in plasma
Evaluation of lipid oxidation
Change at malondialdehyde levels in plasma and red blood cells
Evaluation of nitric oxide metabolites
Change at nitric oxide metabolites levels in serum
Evaluation of plasma antioxidant capacity
Change at oxygen radical absorbance capacity in plasma
Evaluation of enzymatic antioxidant defences
Change at antioxidant enzymes activities in red blood cells
Evaluation of gluthatione cycle
Change at reduced glutathione/oxidized glutathione ratio in red blood cells
Evaluation of red blood cell osmotic fragility
Change of red blood cell osmotic fragility after ex vivo exposure to membrane damage inducers
Evaluation of carotenoids levels
Change at carotenoids levels in plasma and red blood cells
Full Information
NCT ID
NCT03820245
First Posted
October 19, 2018
Last Updated
December 27, 2019
Sponsor
Universidade Federal de Santa Maria
1. Study Identification
Unique Protocol Identification Number
NCT03820245
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 24, 2016 (Actual)
Primary Completion Date
April 15, 2018 (Actual)
Study Completion Date
July 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Atherosclerosis
Keywords
Carotenoid, LDL oxidation, Cardiovascular disease, Antioxidant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bixin
Arm Type
Experimental
Arm Description
Consumption of 0.05 mg bixin/kg b.w. through capsules (once a day) by 7 days in the morning.
Arm Title
Norbixin
Arm Type
Experimental
Arm Description
Consumption of 0.05 mg norbixin/kg b.w. through capsules (once a day) by 7 days in the morning.
Arm Title
Lycopene
Arm Type
Active Comparator
Arm Description
Consumption of 0.05 mg lycopene/kg b.w. through capsules (once a day) by 7 days in the morning.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Consumption of 0.05 mg placebo/kg b.w. through capsules (once a day) by 7 days in the morning.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bixin
Intervention Description
Volunteers consumed bixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
Intervention Type
Dietary Supplement
Intervention Name(s)
Norbixin
Intervention Description
Volunteers consumed norbixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
Intervention Type
Dietary Supplement
Intervention Name(s)
Lycopene
Intervention Description
Volunteers consumed lycopene capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Volunteers consumed placebo capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
Primary Outcome Measure Information:
Title
Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - oxidation rate
Description
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
Title
Evaluation of LDL protein moiety susceptibility to copper induced oxidation
Description
Evaluate the change (Day 7 - Day 0) of loss of tryptophan fluorescence after oxidation induced by copper
Time Frame
Day 0 and Day 7
Title
Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - lag phase
Description
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
Secondary Outcome Measure Information:
Title
Evaluation of protein oxidation
Description
Change at advanced oxidation protein products levels in plasma
Time Frame
Day 0 and Day 7
Title
Evaluation of lipid oxidation
Description
Change at malondialdehyde levels in plasma and red blood cells
Time Frame
Day 0 and Day 7
Title
Evaluation of nitric oxide metabolites
Description
Change at nitric oxide metabolites levels in serum
Time Frame
Day 0 and Day 7
Title
Evaluation of plasma antioxidant capacity
Description
Change at oxygen radical absorbance capacity in plasma
Time Frame
Day 0 and Day 7
Title
Evaluation of enzymatic antioxidant defences
Description
Change at antioxidant enzymes activities in red blood cells
Time Frame
Day 0 and Day 7
Title
Evaluation of gluthatione cycle
Description
Change at reduced glutathione/oxidized glutathione ratio in red blood cells
Time Frame
Day 0 and Day 7
Title
Evaluation of red blood cell osmotic fragility
Description
Change of red blood cell osmotic fragility after ex vivo exposure to membrane damage inducers
Time Frame
Day 7
Title
Evaluation of carotenoids levels
Description
Change at carotenoids levels in plasma and red blood cells
Time Frame
Day 0 and Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Emanuelli, Doctor
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de Santa Maria
City
Santa Maria
State/Province
Rio Grande Do Sul
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data may be shared after article publication.
Learn more about this trial
Effect of Short-term Annatto Carotenoids Supplementation on Oxidative Stress Status in Healthy Individuals
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