- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05149716
Taurine as a Possible Anti-aging Therapy?
Taurine as a Possible Anti-aging Therapy? A Controlled Clinical Trial on Taurine Antioxidant Activity in Women Aged 55 to 70 Years
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sao Paulo
-
Ribeirao Preto, Sao Paulo, Brazil, 14040-907
- Escola de Educação Física e Esporte de Ribeirão Preto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Taurine supplementation
Taurine supplementation composed of capsules of taurine powder.
Dosage: 1.5 gram/day Frequency: 1 time/day Duration: 16 weeks
|
Taurine supplementation in capsules of 500 grams of taurine powder, total dosage: 1.5 gram/day
Other Names:
|
PLACEBO_COMPARATOR: Placebo supplementation
Placebo supplementation composed of capsules of starch powder.
Dosage: 1.5 gram/day Frequency: 1 time/day Duration: 16 weeks
|
Placebo supplementation in capsules of 500 grams of starch powder, total dosage: 1.5 gram/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in blood oxidative stress marker measurement - Superoxide Dismutase (SOD).
Time Frame: sixteen weeks
|
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).
Time Frame: sixteen weeks
|
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).
Time Frame: sixteen weeks
|
The malondialdehyde (MDA) were calculated at 16 weeks in comparision to the baseline.
|
sixteen weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Taurine_aging
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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