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Completed

NCT Number: NCT03820245

Effect of Short-term Annatto Carotenoids Supplementation on Oxidative Stress Status 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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bixin

Dietary Supplement

Volunteers consumed bixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)

Norbixin

Dietary Supplement

Volunteers consumed norbixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)

lycopene

Dietary Supplement

Volunteers consumed lycopene capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)

Placebo

Dietary Supplement

Volunteers consumed placebo capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade Federal de Santa Maria

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2019
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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