Normal Values of Oxidative Stress, Taurine, and Related Markers

Oxidative Stress Clinical Trial

Official title:

Normal Values of Oxidative Stress, Taurine, and Related Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649777
• Other study ID #: 15-2091
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: N/A
• First received: January 4, 2016
• Last updated: January 17, 2018
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oxidative Stress

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative stress marker: TBARS	Single Draw for one-time analysis	Time 0
Primary	Metabolite antioxidant: Taurine	Single Draw for one-time analysis	Time 0
Secondary	Inflammation marker: Supper oxide dismutase (SOD)	Single Draw for one-time analysis	Time 0
Secondary	Inflammation marker: TGFß	Single Draw for one-time analysis	Time 0
Secondary	Inflammation marker: myeloperoxidase	Single Draw for one-time analysis	time 0
Secondary	Metabolites: S-adenosylmethionine and S-adenosylhomocysteine	Single Draw for one-time analysis (same units)	Time 0
Secondary	Vascular function: Thromboxane B2 metabolites	Single Draw for one-time analysis (same units)	Time 0
Secondary	Oxidative stress: dityrosine	Single Draw for one-time analysis	Time 0
Secondary	Inflammation markers: IL1a, IL-1ß, IL10, TNFa	Single Draw for one-time analysis; ELISA assay (same units)	Time 0
Secondary	Inflammation markers: cytokines: IL1a, IL-1ß IL-1ra, IL6, IL8, IL17, MCP-1,MIP-1, MIP1a, MIPß	Single Draw for one-time analysis; Luminex assay (same units)	Time 0
Secondary	Inflammation markers: cytokines: TNFa, IL4, IL10 and IL12	Single Draw for one-time analysis; high sensitivity Luminex assay (same units)	Time 0
Secondary	Inflammation marker: high sensitivity CRP	Single Draw for one-time analysis	Time 0