Completed

Development of a Metabolic Assessment Tool for Chronic Kidney Disease

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What is being tested

Fish Oil

Dietary Supplement
Who is being recruted

Urogenital Diseases+8

+ Autoimmune Diseases

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 65 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: June 2008
See protocol details

Summary

Principal SponsorUniversity of California, Davis
Last updated: May 30, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2008

Actual date on which the first participant was enrolled.

It is unclear how metabolomic profiles of individuals change in response to short-term intervention with omega-3 fatty acids. It is necessary to establish the means and standard deviations in the levels of omega-3 fatty acids and their related metabolites in healthy subjects and in different disease states in order to better understand the mechanisms related to lipid metabolism of metabolic diseases that are modified by omega-3 fatty acids. Specifically, the project will examine the metabolomic profiles of healthy controls and patients with immunoglobulin A nephropathy (IgAN) before and after an omega-3 fatty acid intervention. The IgAN patient samples were obtained from collaborators from a previously completed project. The healthy subjects were tested in a small pilot trial conducted at UC Davis as described below. Twelve healthy volunteers willing and able to take 6 g of fish oil for 6 weeks were recruited from the general UC Davis population including students, faculty, and staff. The volunteers were recruited by personal communication at seminars and other school-related activities as well as flyers posted on campus. The volunteers were contacted and scheduled for a screening and consent visit. Subjects who met all eligibility criteria and signed a consent form were then scheduled for a baseline blood draw and to collect a first morning urine sample. A research team member contacted each subject the day before their first scheduled study date to confirm and remind the subject about fasting, about collecting the first morning urine void, and the time and location of the study. On each study visit, the participants came to the Ragle Human Nutrition Center (1283 Academic Surge) between 7 and 9 am after an overnight fast, at which point they were weighed (clothed but with no shoes) on a digital scale and their height was measured. A registered phlebotomist drew 20 mL of blood by venipuncture for their baseline blood draw. Subjects also brought in their first morning urine sample at this time. Subjects were then given their fish oil capsules that were separated in a Ziploc bag for each week of the intervention. Subjects took the fish oil capsules at home at their own discretion but study personnel suggested they take the capsules after their last meal of the day and before bed each evening. Study personnel contacted subjects throughout the course of the study by phone and/or e-mail to make sure that there were no adverse effects from the fish oil and to ensure compliance. Subjects were instructed to record their diets through 24-hour dietary recalls before the baseline blood draw, and at 3 additional time points throughout the study. Immediately after blood collection, the researchers separated the red blood cells and peripheral blood mononuclear cells (PBMC) from the plasma, aliquoted the samples, and then stored them in a -70°C freezer for future analysis.

Principal SponsorUniversity of California, Davis
Last updated: May 30, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAutoimmune DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisImmune System DiseasesKidney DiseasesNephritisUrologic DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesGlomerulonephritis, IGA

Criteria

9 inclusion criteria required to participate
Able to carry out first morning urine collection

Able to come to the Ragle Center at the designated times

Able to give blood

Able to stop or avoid eating seafood and seaweed for 6 weeks

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9 exclusion criteria prevent from participating
Currently has some form of anemia (or unsure)

Currently taking prescription medications that alter lipid metabolism (such as HMG CoA reductase inhibitors, PPAR agonists, steroids) and/or anti-coagulants

Diagnosed with a disease by their physician

Has an existing health condition or concern

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of California Davis

Davis, United StatesOpen University of California Davis in Google Maps
CompletedOne Study Center