NCT03820245 is a NA clinical trial of Bixin in Oxidative Stress, sponsored by Universidade Federal de Santa Maria.

Who is sponsoring NCT03820245?

NCT03820245 is sponsored by Universidade Federal de Santa Maria.

What drugs are being tested in NCT03820245?

Interventions in NCT03820245: Bixin, Norbixin, Lycopene, Placebo.

What condition does NCT03820245 study?

NCT03820245 studies Oxidative Stress, Atherosclerosis.

Is NCT03820245 still recruiting?

NCT03820245 is currently completed. Last updated 2 January 2020.

Last reviewed 2020-01-02 · How we verify

NCT03820245

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 2 January 2020

What this trial tests

NA trial testing Bixin in Oxidative Stress in 16 participants. Completed in 25 July 2018.

Timeline

24 August 2016

Primary endpoint
15 April 2018

25 July 2018

Quick facts

Lead sponsor	Universidade Federal de Santa Maria
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	16
Start date	24 August 2016
Primary completion	15 April 2018
Estimated completion	25 July 2018
Sites	1 location across Brazil

Drugs / interventions tested

Bixin
Norbixin
Lycopene (LYCOPENE) — full drug profile →
Placebo

Conditions studied

Oxidative Stress — all drugs for Oxidative Stress →
Atherosclerosis — all drugs for Atherosclerosis →

Sponsor

Universidade Federal de Santa Maria — full company profile →

Who can join

Adults 18 to 35, any sex, with Oxidative Stress or Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Anti-oxidative stress treatment and current clinical trials.
Zhang CY, Yang M. · · 2024 · cited 3× · PMID 38495278 · DOI 10.4254/wjh.v16.i2.294

Verify or expand the search:

Other recruiting trials for Oxidative Stress

Currently open trials in the same condition.

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NCT07369232 — Cerebral Hemodynamic Effects of Oxygen and Antioxidants (CHEOXANT) · NA · recruiting

Other Universidade Federal de Santa Maria trials

Trials by the same sponsor.

NCT07584460 — Juçara (Euterpe Edulis Martius) Supplementation Effect in Muscle Protection, Performance and Soreness in Lower Limbs Aft · NA · completed
NCT05948722 — Behavioral Intervention Program Based on Motivational Interview · NA · active not recruiting
NCT06371287 — Effect of Musical Auditory Training on Subjects With Tinnitus Disorder · NA · recruiting
NCT04418700 — Effects of the Breath Stacking Technique After Upper Abdominal Surgery · NA · completed
NCT04262011 — Effect of Non-surgical Periodontal Treatment and C-reactive Protein Levels in Hemodialysis Patients · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03820245 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universidade Federal de Santa Maria
Last refreshed: 2 January 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03820245.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing