NCT05149716

Brief Summary

Among the strategies that can improve the body's ability to counteract oxidative stress, the use of nutritional antioxidants has been investigated. Taurine is a "semi-essential" amino acid, also called a nitrogen compound, which has been used as an effective antioxidant due to its ability to neutralize hypochlorous acid, an extremely toxic oxidant produced by leukocytes in the inflammatory process in humans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

November 19, 2021

Last Update Submit

December 2, 2021

Conditions

Keywords

AgingOxidative StressTaurineNutritional SupplementationTherapeutic Strategy

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in blood oxidative stress marker measurement - Superoxide Dismutase (SOD).

    The superoxide dismutase (SOD) activity in erythrocytes was evaluated by the spectrophotometric method, and were calculated at 16 weeks in comparision to the baseline.

    sixteen weeks

  • Change from baseline in blood oxidative stress marker measurement - Glutathione reductase (GR).

    Glutathione reductase (GR) activity was determined by the spectrophotometric method at 37 ºC/340nm after the oxidation of NADPH in the presence of oxidized glutathione, and were calculated at 16 weeks in comparision to the baseline.

    sixteen weeks

  • Change from baseline in blood oxidative stress marker measurement - Malondialdehyde (MDA).

    The malondialdehyde (MDA) were calculated at 16 weeks in comparision to the baseline.

    sixteen weeks

Study Arms (2)

Taurine supplementation

EXPERIMENTAL

Taurine supplementation composed of capsules of taurine powder. Dosage: 1.5 gram/day Frequency: 1 time/day Duration: 16 weeks

Dietary Supplement: Taurine

Placebo supplementation

PLACEBO COMPARATOR

Placebo supplementation composed of capsules of starch powder. Dosage: 1.5 gram/day Frequency: 1 time/day Duration: 16 weeks

Dietary Supplement: Placebo

Interventions

TaurineDIETARY_SUPPLEMENT

Taurine supplementation in capsules of 500 grams of taurine powder, total dosage: 1.5 gram/day

Also known as: Taurine supplementation in capsules of 500 grams of taurine powder, total dosage: 1.5 grams/day
Taurine supplementation
PlaceboDIETARY_SUPPLEMENT

Placebo supplementation in capsules of 500 grams of starch powder, total dosage: 1.5 gram/day

Placebo supplementation

Eligibility Criteria

Age55 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Had being aged 55-70 years;
  • Female;
  • Post-menopausal;
  • Sedentary (not practicing physical exercise for at least 6 months).

You may not qualify if:

  • Chronic kidney diseases;
  • Infectious contagious diseases;
  • Coronary heart disease;
  • Smokers
  • Alcoholics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola de Educação Física e Esporte de Ribeirão Preto

Ribeirão Preto, São Paulo, 14040-907, Brazil

Location

Related Publications (9)

  • Schaffer S, Kim HW. Effects and Mechanisms of Taurine as a Therapeutic Agent. Biomol Ther (Seoul). 2018 May 1;26(3):225-241. doi: 10.4062/biomolther.2017.251.

    PMID: 29631391BACKGROUND
  • Tadolini B, Pintus G, Pinna GG, Bennardini F, Franconi F. Effects of taurine and hypotaurine on lipid peroxidation. Biochem Biophys Res Commun. 1995 Aug 24;213(3):820-6. doi: 10.1006/bbrc.1995.2203.

    PMID: 7654243BACKGROUND
  • Oliveira MW, Minotto JB, de Oliveira MR, Zanotto-Filho A, Behr GA, Rocha RF, Moreira JC, Klamt F. Scavenging and antioxidant potential of physiological taurine concentrations against different reactive oxygen/nitrogen species. Pharmacol Rep. 2010 Jan-Feb;62(1):185-93. doi: 10.1016/s1734-1140(10)70256-5.

    PMID: 20360629BACKGROUND
  • Lourenco R, Camilo ME. Taurine: a conditionally essential amino acid in humans? An overview in health and disease. Nutr Hosp. 2002 Nov-Dec;17(6):262-70.

    PMID: 12514918BACKGROUND
  • Sun Jang J, Piao S, Cha YN, Kim C. Taurine Chloramine Activates Nrf2, Increases HO-1 Expression and Protects Cells from Death Caused by Hydrogen Peroxide. J Clin Biochem Nutr. 2009 Jul;45(1):37-43. doi: 10.3164/jcbn.08-262. Epub 2009 Jun 30.

    PMID: 19590705BACKGROUND
  • Rosa FT, Freitas EC, Deminice R, Jordao AA, Marchini JS. Oxidative stress and inflammation in obesity after taurine supplementation: a double-blind, placebo-controlled study. Eur J Nutr. 2014 Apr;53(3):823-30. doi: 10.1007/s00394-013-0586-7. Epub 2013 Sep 25.

    PMID: 24065043BACKGROUND
  • De Carvalho FG, Galan BSM, Santos PC, Pritchett K, Pfrimer K, Ferriolli E, Papoti M, Marchini JS, de Freitas EC. Taurine: A Potential Ergogenic Aid for Preventing Muscle Damage and Protein Catabolism and Decreasing Oxidative Stress Produced by Endurance Exercise. Front Physiol. 2017 Sep 20;8:710. doi: 10.3389/fphys.2017.00710. eCollection 2017.

    PMID: 28979213BACKGROUND
  • Chupel MU, Minuzzi LG, Furtado GE, Santos ML, Ferreira JP, Filaire E, Teixeira AM. Taurine supplementation reduces myeloperoxidase and matrix-metalloproteinase-9 levels and improves the effects of exercise in cognition and physical fitness in older women. Amino Acids. 2021 Mar;53(3):333-345. doi: 10.1007/s00726-021-02952-6. Epub 2021 Feb 13.

    PMID: 33586039BACKGROUND
  • Marcinkiewicz J, Kontny E. Taurine and inflammatory diseases. Amino Acids. 2014 Jan;46(1):7-20. doi: 10.1007/s00726-012-1361-4. Epub 2012 Jul 19.

MeSH Terms

Interventions

Taurine

Intervention Hierarchy (Ancestors)

Alkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Ellen C Freitas, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Supplement capsule packages were labeled as "Supplement A" and "Supplement B" and the nutrient (taurine or placebo- starch) was revealed after the end of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blind placebo controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2021

First Posted

December 8, 2021

Study Start

January 13, 2020

Primary Completion

June 15, 2020

Study Completion

July 3, 2020

Last Updated

December 8, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations