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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Completed

CT.gov ID

NCT03542240

Collaborator

(none)

Enrollment

Location

Arm

25.8

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity High Blood Pressure High Cholesterol Type2 Diabetes Heart Diseases	Dietary Supplement: Curcumin	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 19, 2018

Actual Primary Completion Date :

Nov 13, 2020

Actual Study Completion Date :

Nov 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Curcumin	Dietary Supplement: Curcumin 500 milligram daily supplement

Arm

Intervention/Treatment

Experimental: Curcumin

Dietary Supplement: Curcumin

500 milligram daily supplement

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Willing and able to comply with the study protocol

Exclusion Criteria:

Diabetes
Established cardiovascular disease
Pre-existing liver disease other than NAFLD
Chronic kidney disease (Stage 4 and 5)
Rheumatological disease
Active malignancy
Alcohol consumption greater than 7 drinks per week for females and greater than 14 drinks per week for males
Current use of metformin and/or steroids
Curcumin supplementation
Females of child-bearing potential (NOT of child-bearing potential is defined as s/p hysterectomy or post-menopausal.)
Prisoners/wards of the state and individuals with limited English proficiency