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Normal Values of Oxidative Stress, Taurine, and Related Markers

Normal Values of Oxidative Stress, Taurine, and Related Markers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02649777
Enrollment
22
Registered
2016-01-07
Start date
2016-01-31
Completion date
2017-12-31
Last updated
2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

Keywords

oxidative stress

Brief summary

The role of oxidative stress in disease pathology is increasingly recognized. At present, the development of biomarkers of this state is in its infancy and the availability of clinically validated assays is lacking. This study will better determine normal values for specific biomarkers of oxidative stress. It will also investigate normal values of taurine, a natural occurring oxidative stress protectant. A primary and specific application of this data is for the evaluation of oxidative stress, levels of the natural protectant taurine, and of associated inflammation in the context of cystathionine β-synthase (ClinicalTrials.gov study: Oxidative Stress Markers in Inherited Homocystinuria and the Impact of Taurine).

Detailed description

This study is a one-time collection of blood and urine samples in healthy individuals. Subjects have to be fasting for 3 hours prior to the blood sampling. A maximum of 7.5 mLs of blood (1 and 1/5 teaspoon) and a urine sample will be collected.

Interventions

None listed

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Age: Over 8 years old and less than 50 years

Exclusion criteria

* Pregnancy: Females who are pregnant or lactating will be excluded from the study as the influence of pregnancy on the markers is not known nor is the impact of pregnancy on taurine known. * Antioxidant use: Individuals taking taurine, over the counter energy drinks containing taurine or other high dose antioxidants such as Vitamin C or E, coenzyme Q, carotenes, selenium will be excluded as such intake will likely impact laboratory results. * Inflammatory status: * Individuals who have a significant chronic illness or state that has a known or suspected marked inflammatory component or oxidative stress component will be excluded from the study as the illness will impact inflammatory markers. * Patients with an acute illness, which may impact inflammatory biomarkers, will be postponed for study entry until the acute illness is resolved. Entry into the study at a later day will be offered. The study visit will not be conducted within 3 weeks of the acute illness. * Smoking within the past 12 months will be excluded.

Design outcomes

Primary

MeasureTime frameDescription
Oxidative stress marker: TBARSTime 0Single Draw for one-time analysis
Metabolite antioxidant: TaurineTime 0Single Draw for one-time analysis

Secondary

MeasureTime frameDescription
Inflammation marker: myeloperoxidasetime 0Single Draw for one-time analysis
Metabolites: S-adenosylmethionine and S-adenosylhomocysteineTime 0Single Draw for one-time analysis (same units)
Vascular function: Thromboxane B2 metabolitesTime 0Single Draw for one-time analysis (same units)
Oxidative stress: dityrosineTime 0Single Draw for one-time analysis
Inflammation marker: Supper oxide dismutase (SOD)Time 0Single Draw for one-time analysis
Inflammation markers: cytokines: IL1α, IL-1β IL-1ra, IL6, IL8, IL17, MCP-1,MIP-1, MIP1α, MIPβTime 0Single Draw for one-time analysis; Luminex assay (same units)
Inflammation markers: cytokines: TNFα, IL4, IL10 and IL12Time 0Single Draw for one-time analysis; high sensitivity Luminex assay (same units)
Inflammation marker: high sensitivity CRPTime 0Single Draw for one-time analysis
Inflammation markers: IL1α, IL-1β, IL10, TNFαTime 0Single Draw for one-time analysis; ELISA assay (same units)
Inflammation marker: TGFβTime 0Single Draw for one-time analysis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026