Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome

A typical diet in the United States, also known as Western diet, is very high in sugars and
saturated fat, and poor in food such as fruits, vegetables, fish and whole grains. This type
of diet is associated with higher risk to develop obesity and other health problems such as
high blood pressure, high cholesterol, Type 2 diabetes, and heart disease. Western diet can
also cause changes in the gut that allow bacteria that are typically only present in the gut
to leak out into the bloodstream. It is thought that having gut bacteria in the bloodstream
may play a role in the development of diseases like Type 2 diabetes and heart disease.

Curcumin is a dietary supplement that comes from the root of the turmeric plant, and it may
have an effect on the function of the gut and the leakage of gut bacteria into the
bloodstream. The purpose of this research study is to evaluate the effects of daily curcumin
dietary supplements on the function of the gut in subjects who are at risk for cardiovascular
and metabolic diseases, for example they have increased blood pressure, increase waist
circumference and high triglycerides (fat in the blood).

Inclusion Criteria:

1. Based on National Institutes of Health (NIH) definition of Metabolic syndrome, the
subject must meet at least 3 of the following criteria:

A. Waist Circumference: Female ≥ 88 cm, Male ≥ 102 cm B. Blood Pressure: ≥ 130/85
mm/Hg and/or treatment with blood pressure lowering medication C. Impaired fasting
glucose or HbA1c (fasting glucose ≥ 100 mg/dl or HgA1c ≥ 5.7 D. HDL-C: Females< 50
mg/dl, Males < 40 mg/dl E. Triglycerides ≥ 150 mg/dl

2. Willing and able to comply with the study protocol

Exclusion Criteria:

1. Diabetes

2. Established cardiovascular disease

3. Pre-existing liver disease other than NAFLD

4. Chronic kidney disease (Stage 4 and 5)

5. Rheumatological disease

6. Active malignancy

7. Alcohol consumption greater than 7 drinks per week for females and greater than 14
drinks per week for males

8. Current use of metformin and/or steroids

9. Curcumin supplementation

10. Females of child-bearing potential (NOT of child-bearing potential is defined as s/p
hysterectomy or post-menopausal.)

11. Prisoners/wards of the state and individuals with limited English proficiency