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OpenTrials
Completed

NCT Number: NCT02649777

Normal Values of Oxidative Stress, Taurine, and Related Markers

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).

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Key information

Conditions

Age range

8 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Oxidative stress marker: TBARS

    Time frame: Time 0

    Single Draw for one-time analysis

  2. Metabolite antioxidant: Taurine

    Time frame: Time 0

    Single Draw for one-time analysis

Secondary outcomes

  1. Inflammation marker: Supper oxide dismutase (SOD)

    Time frame: Time 0

    Single Draw for one-time analysis

  2. Inflammation marker: TGFβ

    Time frame: Time 0

    Single Draw for one-time analysis

  3. Inflammation marker: myeloperoxidase

    Time frame: time 0

    Single Draw for one-time analysis

  4. Metabolites: S-adenosylmethionine and S-adenosylhomocysteine

    Time frame: Time 0

    Single Draw for one-time analysis (same units)

  5. Vascular function: Thromboxane B2 metabolites

    Time frame: Time 0

    Single Draw for one-time analysis (same units)

  6. Oxidative stress: dityrosine

    Time frame: Time 0

    Single Draw for one-time analysis

  7. Inflammation markers: IL1α, IL-1β, IL10, TNFα

    Time frame: Time 0

    Single Draw for one-time analysis; ELISA assay (same units)

  8. Inflammation markers: cytokines: IL1α, IL-1β IL-1ra, IL6, IL8, IL17, MCP-1,MIP-1, MIP1α, MIPβ

    Time frame: Time 0

    Single Draw for one-time analysis; Luminex assay (same units)

  9. Inflammation markers: cytokines: TNFα, IL4, IL10 and IL12

    Time frame: Time 0

    Single Draw for one-time analysis; high sensitivity Luminex assay (same units)

  10. Inflammation marker: high sensitivity CRP

    Time frame: Time 0

    Single Draw for one-time analysis

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 7, 2016
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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