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ACTIVE NOT RECRUITING
NCT04098003
PHASE4

Investigation of the Gut Microbiome and Statin Response

Sponsor: Sony Tuteja

View on ClinicalTrials.gov

Summary

There is evidence that the bacteria that naturally reside in the gut can influence how well we respond to medications. Therefore this study will look at how rosuvastatin, a medication used to lower cholesterol levels, may change the bacteria in the gut. Investigators will also examine how the gut bacteria will affect the ability of rosuvastatin to lower cholesterol levels. There will be 4 study visits over the course of about 16 weeks.The expected duration of the study is 2 years. Investigators plan to enroll 100 healthy volunteers during that time.

Official title: INvestigation of the Gut microbiomE and STatin Response (INGEST)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2020-02-06

Completion Date

2026-03-01

Last Updated

2026-03-03

Healthy Volunteers

Yes

Interventions

DRUG

Rosuvastatin

rosuvastatin 20 mg daily or placebo for eight weeks

DRUG

Placebo

Matched placebo control

Locations (1)

University of Pennsylvania

Phildelphia, Pennsylvania, United States