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

NCT03820245 | Completed

• 1 other identifier: 68801917.0.0000.5346
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress; Atherosclerosis

Keywords

Carotenoid; LDL oxidation; Cardiovascular disease; Antioxidant

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Day 0 and Day 7

Secondary Outcomes (8)

• Evaluation of protein oxidation

  Day 0 and Day 7

• Evaluation of lipid oxidation

  Day 0 and Day 7

• Evaluation of nitric oxide metabolites

  Day 0 and Day 7

• Evaluation of plasma antioxidant capacity

  Day 0 and Day 7

• Evaluation of enzymatic antioxidant defences

  Day 0 and Day 7

Study Arms (4)

Bixin

EXPERIMENTAL

Consumption of 0.05 mg bixin/kg b.w. through capsules (once a day) by 7 days in the morning.

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.

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.

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.

Dietary Supplement: Placebo

Interventions

Bixin DIETARY_SUPPLEMENT

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

Bixin

Norbixin DIETARY_SUPPLEMENT

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

Norbixin

Lycopene DIETARY_SUPPLEMENT

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

Lycopene

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal levels of glucose, lipid profile, transaminases, urea and creatine
• Normal blood pressure, weight and body mass index (BMI)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Universidade Federal de Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases

Interventions

bixin; norbixin; Lycopene

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Tatiana Emanuelli, Doctor

  Universidade Federal de Santa Maria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree student

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: January 29, 2019
• Study Start: August 24, 2016
• Primary Completion: April 15, 2018
• Study Completion: July 25, 2018
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

BR (1)