Obesity Clinical Trial
Official title:
Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome
Verified date | January 2021 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | November 13, 2020 |
Est. primary completion date | November 13, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change inintestinal permeability | Measured by level plasma lipopolysaccharide (LPS). A reduction in LPS suggests a reduction in intestinal permeability | Baseline to 12 months | |
Primary | Change in intestinal barrier function | Measured by level of excreted Zonulin in stool samples. A reduction in Zonulin suggests a reduction in intestinal barrier function | Baseline to 12 months |
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