Normal Values of Oxidative Stress, Taurine, and Related Markers
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 8 - 50 |
| Updated: | 1/21/2018 |
| Start Date: | January 2016 |
| End Date: | December 2017 |
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).
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).
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.
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.
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.
We found this trial at
1
site
13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Phone: 720-777-4690
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