Clinical trial NCT05149716: Taurine as a Possible Anti-aging Therapy?
Official title: Taurine as a Possible Anti-aging Therapy? A Controlled Clinical Trial on Taurine Antioxidant Activity in Women Aged 55 to 70 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Keywords: Aging
Oxidative Stress
Taurine
Nutritional Supplementation
Therapeutic Strategy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2021-12-08
Enrollment: 24
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind placebo controlled study
Primary purpose: TREATMENT

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.

Detailed description: Objective: To evaluate the oxidative parameters of women aged 55 to 70 years after 16 weeks of taurine supplementation.

Methods: Twenty-four women age 55 to 70 will be randomly assigned to two groups: control group (GC), supplemented with placebo (1.5 g of starch); and taurine group (GTAU), supplemented with taurine (1.5 g), for 16 weeks. Anthropometry, functional capacity test, taurine, and levels of oxidative stress markers will be determined in pre and post intervention plasma samples. Food consumption will be assessed before, during, and after the intervention. The results will be analyzed by an ANOVA two-way repeated measures mixed model, with the Sidak post hoc (p \< 0.05).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline in blood oxidative stress marker measurement - Superoxide Dismutase (SOD).
timeFrame: sixteen weeks
measure: Change from baseline in blood oxidative stress marker measurement - Glutathione reductase (GR).
timeFrame: sixteen weeks
measure: Change from baseline in blood oxidative stress marker measurement - Malondialdehyde (MDA).
timeFrame: sixteen weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Escola de Educação Física e Esporte de Ribeirão Preto
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Ellen C Freitas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.