Investigation of the Gut Microbiome and Statin Response (INGEST)
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|ClinicalTrials.gov Identifier: NCT04098003|
Recruitment Status : Active, not recruiting
First Posted : September 20, 2019
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Rosuvastatin Drug: Placebo||Phase 4|
The gut microbiome plays an important role in the metabolism of xenobiotics and contributes to the variation in drug response. Atorvastatin, simvastatin and rosuvastatin, three of the most commonly prescribed statin medications, also display evidence for modulation by the gut microbiome.The objective of this study is to understand the interaction between the gut microbiome and host drug response to statin therapy using 16S rRNA sequencing, metagenomics sequencing and bile acid metabolomics.
Aim 1: To compare changes in the gut microbiome in healthy volunteers randomized to an 8-week intervention with rosuvastatin 10mg daily or placebo.
Aim 2: To determine the relationship with gut microbiome, fecal bile acid composition, serum FGF19 levels and the change in plasma LDL-C with rosuvastatin.
This is a randomized, placebo controlled trial to investigate the effects of rosuvastatin on the gut microbiome, fecal bile acids and FGF19 levels. Healthy volunteers will be randomized to rosuvastatin 20 mg daily or placebo for eight weeks in a 2:1 ratio. Participants will be blinded to treatment assignment. Stool and blood will be collected at baseline, 8 weeks, and 12 weeks for 16S sequencing, plasma lipid assays, bile acid metabolites and FGF19 assays. A subgroup of participants at the tails of LDL-C response will undergo metagenomics sequencing.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a randomized, placebo controlled, double blind (participant and outcomes assessor) trial to investigate the effects of rosuvastatin on the gut microbiome. Healthy volunteers will be randomized to rosuvastatin 20 mg daily or placebo for eight weeks in a 2:1 ratio.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Matching placebo capsules will be formulated|
|Primary Purpose:||Basic Science|
|Official Title:||INvestigation of the Gut microbiomE and STatin Response (INGEST)|
|Actual Study Start Date :||February 6, 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
rosuvastatin 20 mg daily for eight weeks
rosuvastatin 20 mg daily or placebo for eight weeks
Other Name: Crestor
Placebo Comparator: Placebo
placebo daily for eight weeks
Matched placebo control
- Change in bacterial abundance [ Time Frame: 8 weeks ]as measured by operational taxonomic units (OTUs)
- Change in LDL-C [ Time Frame: 8 weeks ]low density lipoprotein cholesterol levels (mg/dl)
- Change in fecal bile acid concentrations [ Time Frame: 8 weeks ]concentration of bile acids (nM)
- Change in serum FGF19 levels [ Time Frame: 8 weeks ]Fibroblast growth factor 19 levels (pg/mL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098003
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Sony Tuteja, PharmD, MS||University of Pennsylvania Perelman School of Medicine|