Rosuvastatin and Gut Microbiome in Healthy Subjects

(INGEST Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Sony Tuteja, PharmD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Sony Tuteja

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sony Tuteja, PharmD, MS

Principal Investigator

University of Pennsylvania

Eligibility Criteria

Healthy volunteers aged 18 to 65, without diabetes, hypothyroidism, cancer history, gut inflammation disorders like IBD or celiac disease. Must not have used antibiotics in the last 6 months or be current smokers. Participants should not have cardiovascular diseases, kidney/liver dysfunction, extreme BMI values (<18.5 or >30), bowel resection surgery (except appendectomy), abnormal bowel frequency, and must agree to use birth control.

Inclusion Criteria

I am between 18 and 65 years old.

I understand the study and can agree to participate.

Exclusion Criteria

My liver enzyme levels are higher than normal.

I have diabetes with a fasting glucose level over 125mg/dL.

I have a history of inflammatory bowel diseases like IBD or celiac disease.

Treatment Details

Interventions

• Placebo (Drug)
• Rosuvastatin (HMG-CoA Reductase Inhibitor)

Trial Overview The study is testing how rosuvastatin affects gut bacteria and cholesterol levels in healthy individuals over approximately 16 weeks with four visits. It will also explore how gut bacteria influence the drug's effectiveness at lowering cholesterol.

Participant Groups

Group I: Rosuvastatin Experimental Treatment 1 Intervention

rosuvastatin 20 mg daily for eight weeks

Group II: Placebo Placebo Group 1 Intervention

placebo daily for eight weeks

Rosuvastatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Crestor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Prevention of cardiovascular disease

Approved in Japan as Crestor for:

• Hypercholesterolemia
• Familial hypercholesterolemia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

Sony Tuteja

Lead Sponsor

Trials

2

Patients Recruited

70+