Oxidative StressNCT03820245
Effect of Short-term Annatto Carotenoids Supplementation on Oxidative Stress Status in Healthy Individuals
A study testing Bixin, Norbixin and Lycopene in people with Oxidative Stress and Atherosclerosis, run by Universidade Federal de Santa Maria at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Atherosclerosis
- What is being tested?
- Bixin, Norbixin and Lycopene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Aug 2016to 25 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal levels of glucose, lipid profile, transaminases, urea and creatine
- Normal blood pressure, weight and body mass index (BMI)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Santa Maria
Santa Maria, Rio Grande do Sul
About this study
Official title: Short-term Annatto Carotenoids Supplementation Effect on LDL Susceptibility to Ex-vivo Oxidation and Oxidative Stress Biomarkers in Healthy Individuals
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.
Read the 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.
- Conditions
- Oxidative Stress, Atherosclerosis
- Being tested
- Bixin, Norbixin, Lycopene, Placebo
- Keywords
- Carotenoid, LDL oxidation, Cardiovascular disease, Antioxidant
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BixinDietary supplement
Volunteers consumed bixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
NorbixinDietary supplement
Volunteers consumed norbixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
LycopeneDietary supplement
Volunteers consumed lycopene capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
PlaceboDietary supplement
Volunteers consumed placebo capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
| Study group | Role | What they receive |
|---|---|---|
| Bixin | Experimental | Consumption of 0.05 mg bixin/kg b.w. through capsules (once a day) by 7 days in the morning. Receives: Dietary Supplement: Bixin |
| Norbixin | Experimental | Consumption of 0.05 mg norbixin/kg b.w. through capsules (once a day) by 7 days in the morning. Receives: Dietary Supplement: Norbixin |
| Lycopene | Active comparator | Consumption of 0.05 mg lycopene/kg b.w. through capsules (once a day) by 7 days in the morning. Receives: Dietary Supplement: Lycopene |
| Placebo | Placebo comparator | Consumption of 0.05 mg placebo/kg b.w. through capsules (once a day) by 7 days in the morning. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 and Day 7
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
Measured: Day 0 and Day 7
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
Measured: Day 0 and Day 7
Secondary outcomes (8)
Evaluation of protein oxidation
Change at advanced oxidation protein products levels in plasma
Measured: Day 0 and Day 7
Evaluation of lipid oxidation
Change at malondialdehyde levels in plasma and red blood cells
Measured: Day 0 and Day 7
Evaluation of nitric oxide metabolites
Change at nitric oxide metabolites levels in serum
Measured: Day 0 and Day 7
Evaluation of plasma antioxidant capacity
Change at oxygen radical absorbance capacity in plasma
Measured: Day 0 and Day 7
Evaluation of enzymatic antioxidant defences
Change at antioxidant enzymes activities in red blood cells
Measured: Day 0 and Day 7
Evaluation of gluthatione cycle
Change at reduced glutathione/oxidized glutathione ratio in red blood cells
Measured: Day 0 and Day 7
Evaluation of red blood cell osmotic fragility
Change of red blood cell osmotic fragility after ex vivo exposure to membrane damage inducers
Measured: Day 7
Evaluation of carotenoids levels
Change at carotenoids levels in plasma and red blood cells
Measured: Day 0 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start24 Aug 2016
- Primary completion15 Apr 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisiane Conte, Universidade Federal de Santa Maria
- Investigators
- Tatiana Emanuelli, Doctor, Study director, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820245
- Sponsor's protocol ID
- 68801917.0.0000.5346
- Status last verified
- Dec 2019
- First submitted
- 19 Oct 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared after article publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Annatto Carotenoids Supplementation Effect on LDL Susceptibility to Ex-vivo Oxidation and Oxidative Stress Biomarkers in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03820245
- Acronym / sponsor ID
- 68801917.0.0000.5346
- Conditions
- Oxidative Stress, Atherosclerosis
- Keywords
- Carotenoid, LDL oxidation, Cardiovascular disease, Antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 24 Aug 2016 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bixin | Experimental | Dietary Supplement: BixinConsumption of 0.05 mg bixin/kg b.w. through capsules (once a day) by 7 days in the morning. |
| Norbixin | Experimental | Dietary Supplement: NorbixinConsumption of 0.05 mg norbixin/kg b.w. through capsules (once a day) by 7 days in the morning. |
| Lycopene | Active comparator | Dietary Supplement: LycopeneConsumption of 0.05 mg lycopene/kg b.w. through capsules (once a day) by 7 days in the morning. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboConsumption of 0.05 mg placebo/kg b.w. through capsules (once a day) by 7 days in the morning. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal levels of glucose, lipid profile, transaminases, urea and creatine
- Normal blood pressure, weight and body mass index (BMI)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BixinVolunteers consumed bixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol) | Dietary supplement | Bixin |
| NorbixinVolunteers consumed norbixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol) | Dietary supplement | Norbixin |
| LycopeneVolunteers consumed lycopene capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol) | Dietary supplement | Lycopene |
| PlaceboVolunteers consumed placebo capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol) | Dietary supplement | Placebo |
Primary outcome
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
8 secondary outcomes
Evaluation of protein oxidation
Time frame: Day 0 and Day 7
Evaluation of lipid oxidation
Time frame: Day 0 and Day 7
Evaluation of nitric oxide metabolites
Time frame: Day 0 and Day 7
Evaluation of plasma antioxidant capacity
Time frame: Day 0 and Day 7
Evaluation of enzymatic antioxidant defences
Time frame: Day 0 and Day 7
Evaluation of gluthatione cycle
Time frame: Day 0 and Day 7
Evaluation of red blood cell osmotic fragility
Time frame: Day 7
Evaluation of carotenoids levels
Time frame: Day 0 and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: Undecided. Data may be shared after article publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana Emanuelli, Doctor study director
Universidade Federal de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bixin, Norbixin and Lycopene in people with Oxidative Stress and Atherosclerosis, run by Universidade Federal de Santa Maria at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of LDL lipid moiety susceptibility to copper induced oxidation - oxidation rate (time frame: Day 0 and Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.