Clinical trial NCT02649777: Normal Values of Oxidative Stress, Taurine, and Related Markers
Official title: Normal Values of Oxidative Stress, Taurine, and Related Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxidative Stress
Keywords: oxidative stress
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Individuals older than 8 years and less than 50 years

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxidative stress marker: TBARS
timeFrame: Time 0
measure: Metabolite antioxidant: Taurine
timeFrame: Time 0
Secondary outcomes:
measure: Inflammation marker: Supper oxide dismutase (SOD)
timeFrame: Time 0
measure: Inflammation marker: TGFβ
timeFrame: Time 0
measure: Inflammation marker: myeloperoxidase
timeFrame: time 0
measure: Metabolites: S-adenosylmethionine and S-adenosylhomocysteine
timeFrame: Time 0
measure: Vascular function: Thromboxane B2 metabolites
timeFrame: Time 0
measure: Oxidative stress: dityrosine
timeFrame: Time 0
measure: Inflammation markers: IL1α, IL-1β, IL10, TNFα
timeFrame: Time 0
measure: Inflammation markers: cytokines: IL1α, IL-1β IL-1ra, IL6, IL8, IL17, MCP-1,MIP-1, MIP1α, MIPβ
timeFrame: Time 0
measure: Inflammation markers: cytokines: TNFα, IL4, IL10 and IL12
timeFrame: Time 0
measure: Inflammation marker: high sensitivity CRP
timeFrame: Time 0
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Johan LK Van Hove, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: