Healthy Subjects Clinical Trial
Official title:
Development of a Metabolic Assessment Tool for Chronic Kidney Disease
Verified date | May 2017 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine the variation between individuals in blood lipid metabolites, and the changes in these metabolites in response to omega-3 fatty acids in patients with immunoglobulin A nephropathy (IgAN) and in healthy subjects. The hypothesis is that measuring variation among individuals and changes in response to omega-3 fatty acids comprehensively by using metabolomics will help to identify those individuals who are responders and those who are non-responders to omega-3 fatty acids as an anti-inflammatory intervention.
Status | Completed |
Enrollment | 12 |
Est. completion date | June 2011 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Weight at least 110 pounds or BMI at least 19 - Adult (aged 18-65 years old) - Disclose which medications currently taking - Able to come to the Ragle Center at the designated times - Able to give blood - Able to take 6 g fish oil per day for 6 weeks - Able to carry out first morning urine collection - Able to stop or avoid taking NSAIDS and allergy medications for 6 weeks - Able to stop or avoid eating seafood and seaweed for 6 weeks Exclusion Criteria: - Pregnant or nursing (or unsure if pregnant) - Diagnosed with a disease by their physician - Currently taking prescription medications that alter lipid metabolism (such as HMG CoA reductase inhibitors, PPAR agonists, steroids) and/or anti-coagulants - Currently has some form of anemia (or unsure) - Has an existing health condition or concern - Unable to stop or avoid taking NSAIDS and allergy medications for 6 weeks - Unable to stop or avoid eating seafood or seaweed for 6 weeks - Unable to give blood or do first morning urine collection - Recently recovering from a major injury, infection, or illness (in the last 2-4 weeks) |
Country | Name | City | State |
---|---|---|---|
United States | University of California Davis | Davis | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Urinary oxylipins | Measurement of urinary oxylipins | Baseline vs. 6 weeks | |
Primary | Plasma lipid metabolomic profile | Plasma lipid metabolomic profile includes fatty acids within lipid classes, oxylipins, lipoprotein particle size and distribution | Baseline vs. 6 weeks | |
Secondary | PBMC gene expression | Measurement of changes in gene expression in peripheral blood mononuclear cells | Baseline vs. 6 weeks |
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