Taurine as a Possible Anti-aging Therapy?

A study testing Taurine in people with Oxidative Stress, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 55 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Oxidative Stress
What is being tested?: Taurine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteBrazil
Study dates: 13 Jan 2020to 3 Jul 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Escola de Educação Física e Esporte de Ribeirão Preto
Ribeirão Preto, São Paulo, 14040-907

Other trials in Brazil

About this study

Official title: Taurine as a Possible Anti-aging Therapy? A Controlled Clinical Trial on Taurine Antioxidant Activity in Women Aged 55 to 70 Years

Read the 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).

Conditions: Oxidative Stress
Being tested: Taurine, Placebo
Keywords: Aging, Oxidative Stress, Taurine, Nutritional Supplementation, Therapeutic Strategy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TaurineDietary supplement
Also called Taurine supplementation in capsules of 500 grams of taurine powder, total dosage: 1.5 grams/day
Taurine supplementation in capsules of 500 grams of taurine powder, total dosage: 1.5 gram/day
PlaceboDietary supplement
Placebo supplementation in capsules of 500 grams of starch powder, total dosage: 1.5 gram/day

Study groups in NCT05149716
Study group	Role	What they receive
Taurine supplementation	Experimental	Taurine supplementation composed of capsules of taurine powder. Dosage: 1.5 gram/day Frequency: 1 time/day Duration: 16 weeks Receives: 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 Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: sixteen weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 20203 Jul 2020

First posted8 Dec 2021
Study start13 Jan 2020
Primary completion15 Jun 2020
Study completion3 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Oxidative StressStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double-blind placebo controlled study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05149716
Sponsor's protocol ID: Taurine_aging
Status last verified: Dec 2021
First submitted: 19 Nov 2021
Last updated: 8 Dec 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 29631391
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.
PubMed 7654243
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.
PubMed 20360629
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.
PubMed 12514918
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.
PubMed 19590705
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.
PubMed 24065043
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.
PubMed 28979213
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.
PubMed 33586039
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.
PubMed 22810731

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Oxidative Stress trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Taurine as a Possible Anti-aging Therapy? A Controlled Clinical Trial on Taurine Antioxidant Activity in Women Aged 55 to 70 Years
ClinicalTrials.gov ID: NCT05149716
Acronym / sponsor ID: Taurine_aging
Conditions: Oxidative Stress
Keywords: Aging, Oxidative Stress, Taurine, Nutritional Supplementation, Therapeutic Strategy
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of Sao PauloUniversity, hospital or other
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Study start: 13 Jan 2020 (actual)
Primary completion: 15 Jun 2020 (actual)
Study completion: 3 Jul 2020 (actual)
First posted: 8 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Double-blind placebo controlled study

Arm	Type	Receives
Taurine supplementation	Experimental	Dietary Supplement: TaurineTaurine supplementation composed of capsules of taurine powder. Dosage: 1.5 gram/day Frequency: 1 time/day Duration: 16 weeks
Placebo supplementation	Placebo comparator	Dietary Supplement: PlaceboPlacebo supplementation composed of capsules of starch powder. Dosage: 1.5 gram/day Frequency: 1 time/day Duration: 16 weeks

Who may qualify

Ages: 55 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TaurineAlso: Taurine supplementation in capsules of 500 grams of taurine powder, total dosage: 1.5 grams/dayTaurine supplementation in capsules of 500 grams of taurine powder, total dosage: 1.5 gram/day	Dietary supplement	Taurine supplementation
PlaceboPlacebo supplementation in capsules of 500 grams of starch powder, total dosage: 1.5 gram/day	Dietary supplement	Placebo supplementation

Primary outcome

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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
Background: PubMed 29631391Schaffer 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.
Background: PubMed 7654243Tadolini 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.
Background: PubMed 20360629Oliveira 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.
Background: PubMed 12514918Lourenco 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.
Background: PubMed 19590705Sun 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.
Background: PubMed 24065043Rosa 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.
Background: PubMed 28979213De 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.
Background: PubMed 33586039Chupel 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.
Results publication: PubMed 22810731Marcinkiewicz 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ellen C Freitas, PhD principal investigator

University of Sao Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Taurine in people with Oxidative Stress, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in blood oxidative stress marker measurement - Superoxide Dismutase (SOD). (time frame: sixteen weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05149716, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.