Method Validation for New Nitrogen/Sulfur Species Analysis Techniques

Redox Status Clinical Trial

Official title:

Method Validation for New Nitrogen/Sulfur Species Analysis Techniques

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03512535
• Other study ID #: 31426
• Status: Active, not recruiting
• Start date: January 29, 2018
• Est. completion date: November 2024

Study information

• Verified date: March 2021
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Plasma redox status is well known to alter with age but previously differences have only been reported for two specific redox couples; reduced and oxidized cysteine and reduced and oxidized glutathione. (Jones DP, Rejuvenation Res. 2006) The overall aim of this project is to develop new methods to determine how other Reactive Nitrogen and Sulfur species, such as free and protein-bound thiols (organic compounds that contain a Sulfhydryl group, -SH) and Hydrogen Sulfide (H2S) change with age and gender in a medium-sized cohort of healthy individuals (n=100 of either sex; age 18-70).

Our group has recently developed a novel analytical platform to measure thiol-containing compounds in biological samples that is based on the reaction with the thiol-alkylating agent N-ethylmaleimide (NEM). We have used this chemical for years as stabilisation agent in other analyses to quantify Nitric Oxide metabolites.(Feelisch et al, FASEB 2002 and Levett et al, Sci Rep 2011) We now wish to develop a similar method to measure thiol containing compounds using a novel rapid LC-MS/MS based technology for screening large numbers of individuals.

The project will therefore have 2 stages:

1. Initial method development will require occasional use of whole blood, plasma and red blood cells to establishing optimal conditions. E.g. to compare heparin and EDTA as anticoagulants to serum; investigate effects of temperature and pH; identify optimal concentration of derivatisation/reduction agents and optimal reaction times.

2. We then aim to establish the normal distribution of these novel compounds across healthy individuals of different gender and varying ages.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or above

• Currently healthy (i.e. no inter-current illness/infection)

• Capacity and ability to give written informed consent

Exclusion Criteria:

• Current or previous smoker

• Other medical co-morbidity (e.g. hypertension, diabetes, asthma, COPD, cardiovascular disease, current or previous malignant disease etc.)

• Surgery within previous 28 days

• Excessive alcohol intake (i.e above UK's recommended intake limit of 14 units per week).

• Pregnant or currently breast-feeding

• On current medication

• Taken vitamins / minerals / herbal remedies within previous 28 days

• Difficult venous access

• Needle phobia

• Participating in another similar/conflicting research study already

Related Conditions & MeSH terms

• Redox Status

Locations

Country	Name	City	State
United Kingdom	University of Southampton	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of reactive (nitrogen or sulfur containing) species		Baseline