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

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

Sponsors

Lead Sponsor: Virginia Commonwealth University

Source Virginia Commonwealth University
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).

Overall Status Completed
Start Date 2018-09-19
Completion Date 2020-11-13
Primary Completion Date 2020-11-13
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change inintestinal permeability Baseline to 12 months
Change in intestinal barrier function Baseline to 12 months
Enrollment 15
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Curcumin

Description: 500 milligram daily supplement

Arm Group Label: Curcumin

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Susan Wolver, MD Principal Investigator Virginia Commonwealth University
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Virginia Commonwealth University
Location Countries

United States

Verification Date

2021-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Curcumin

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

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