TMAO Study

STUDY BASICS

Do you have chronic kidney disease? Are you 18-75 years old? If so, you may be able to take part in a research study to help learn more about why people with kidney disease have an increased risk of heart disease complications, and to find out if taking a nutritional supplement can potentially help reduce this risk. Compensation provided.

STUDY PURPOSE

People who have chronic kidney disease often develop heart disease, but the relationship between the two conditions is not well understood. Many people with heart-related complications from kidney disease have high levels of a substance in the blood called trimethylamine-N-oxide (TMAO). A nutritional supplement called diindolymethane (DIM), which is found in cruciferous vegetables like broccoli and cabbage, may decrease with the body’s ability to create TMAO. The purpose of this study is to learn more about the formation of TMAO in patients with chronic kidney disease, and to find out if taking DIM as a nutritional supplement decreases the body’s ability to create TMAO. DIM is available over-the-counter in many health food stores that sell natural products and nutritional supplements. Researchers hope their findings will lead to better treatments for people with kidney disease.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18-75
• Diagnosed with chronic kidney disease
• Free from liver disease

WHAT PARTICIPANTS CAN EXPECT

Participation involves a screening visit and 4 study visits over 12 weeks. Study procedures include a review of your medical record and collection of blood, urine, and stool samples. Participants will be randomly assigned (like the flip of a coin) to receive either the nutritional supplement DIM or placebo. The placebo looks and tastes like DIM, but does not contain any active DIM. Participants will be asked to take the DIM or placebo twice a day for four weeks.