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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820245
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Lisiane Conte, Universidade Federal de Santa Maria

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Atherosclerosis Dietary Supplement: Bixin Dietary Supplement: Norbixin Dietary Supplement: Lycopene Dietary Supplement: Placebo Not Applicable

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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
Drug Information available for: Lycopene

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bixin
Consumption of 0.05 mg bixin/kg b.w. through capsules (once a day) by 7 days in the morning.
 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.
 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.
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Evaluation of protein oxidation [ Time Frame: Day 0 and Day 7 ]
    Change at advanced oxidation protein products levels in plasma

  2. Evaluation of lipid oxidation [ Time Frame: Day 0 and Day 7 ]
    Change at malondialdehyde levels in plasma and red blood cells

  3. Evaluation of nitric oxide metabolites [ Time Frame: Day 0 and Day 7 ]
    Change at nitric oxide metabolites levels in serum

  4. Evaluation of plasma antioxidant capacity [ Time Frame: Day 0 and Day 7 ]
    Change at oxygen radical absorbance capacity in plasma

  5. Evaluation of enzymatic antioxidant defences [ Time Frame: Day 0 and Day 7 ]
    Change at antioxidant enzymes activities in red blood cells

  6. Evaluation of gluthatione cycle [ Time Frame: Day 0 and Day 7 ]
    Change at reduced glutathione/oxidized glutathione ratio in red blood cells

  7. 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

  8. Evaluation of carotenoids levels [ Time Frame: Day 0 and Day 7 ]
    Change at carotenoids levels in plasma and red blood cells


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Brazil
Universidade Federal de Santa Maria
Santa Maria, Rio Grande Do Sul, Brazil
Sponsors and Collaborators
Universidade Federal de Santa Maria
Investigators
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Study Director: Tatiana Emanuelli, Doctor Universidade Federal de Santa Maria
More Information
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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.

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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
Keywords provided by Lisiane Conte, Universidade Federal de Santa Maria:
Carotenoid
LDL oxidation
Cardiovascular disease
Antioxidant
Additional relevant MeSH terms:
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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