About this trial
The goal of this study is to test the efficacy and feasibility of Colesevelam administration (50% of the recommended dose) to reduce serum PFAS concentration in the Veteran population who have serum PFAS levels that exceed the National Academies Science criteria (PFASsix \> 20 ng/ml) using a double blind-placebo controlled study. Based on PFAS prevalence in serum samples, we anticipate recruiting up to n=500 Veterans to meet the goal of n=50 study participants to receive intervention or placebo. The primary outcome will be initial and final PFAS content in serum (total and 7 individual PFAS). The secondary outcome will be initial and final serum biomarkers related to lipid metabolism. As an exploratory aspect to the proposal, we will also measure fecal PFAS, bile acids, and microbial diversity to examine associations between PFAS content and bile acid levels and microbiome. Fecal PFAS, bile acid content, and microbiome may also be measured.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female Veterans aged 25- 65 who have serum PFAS >20 ng/ml exceeding National Academy of Science guidance.
Written informed consent will be obtained.
Outpatient.
Agreeable to participate in sharable data and biorepository.
Disqualifiers
None
Trial design
Crossover
Treatments tested in this trial
Colesevelam
DrugA double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam (3 x 625 mg tablets daily) for 12 weeks
Placebo
DrugA double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam
Treatment groups
Trial outcomes
Primary outcomes
PFAS content
Reduction PFAS content in serum (total and 7 individual PFAS).
Secondary outcomes
Serum biomarkers
The secondary outcome will be initial and final serum biomarkers related to lipid metabolism.
Other outcomes
Exploratory
As an exploratory aspect to the proposal, we will also measure fecal PFAS, bile acids, and microbial diversity to examine associations between PFAS content and bile acid levels and microbiome.
Sponsors and contacts
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University of Rhode Island
Lead sponsor
Louisville VA Medical Center
Collaborator
University of Louisville
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
This trial is not recruiting at the moment. You can still explore other options: