Heart Diseases, High Blood Pressure, High Cholesterol, Obesity, Type2 Diabetes
Conditions
Keywords
curcumin, microbiome, dietary supplements, gut bacteria
Brief summary
This study will investigate the effects of curcumin on the structure/function of the body by investigating whether targeted improvement of intestinal barrier function by supplementation with oral curcumin will result in attenuation of lipopolysaccharide (LPS) translocation and/or intestinal inflammation.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTCurcumin
500 milligram daily supplement
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change inintestinal permeability | Baseline to 12 months | Measured by level plasma lipopolysaccharide (LPS). A reduction in LPS suggests a reduction in intestinal permeability |
| Change in intestinal barrier function | Baseline to 12 months | Measured by level of excreted Zonulin in stool samples. A reduction in Zonulin suggests a reduction in intestinal barrier function |
Countries
United States
Outcome results
None listed