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

Primary Purpose

Obesity, High Blood Pressure, High Cholesterol

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Curcumin

About this trial

This is an interventional prevention trial for Obesity focused on measuring curcumin, microbiome, dietary supplements, gut bacteria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:
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
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

Sites / Locations

Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Curcumin

Arm Description

Outcomes

Primary Outcome Measures

Change inintestinal permeability

Measured by level plasma lipopolysaccharide (LPS). A reduction in LPS suggests a reduction in intestinal permeability

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03542240

First Posted

May 18, 2018

Last Updated

January 25, 2021

Sponsor

Virginia Commonwealth University

1. Study Identification

Unique Protocol Identification Number

NCT03542240

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

September 19, 2018 (Actual)

Primary Completion Date

November 13, 2020 (Actual)

Study Completion Date

November 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, High Blood Pressure, High Cholesterol, Type2 Diabetes, Heart Diseases

Keywords

curcumin, microbiome, dietary supplements, gut bacteria

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Curcumin

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Curcumin

Intervention Description

500 milligram daily supplement

Primary Outcome Measure Information:

Title

Change inintestinal permeability

Description

Measured by level plasma lipopolysaccharide (LPS). A reduction in LPS suggests a reduction in intestinal permeability

Time Frame

Baseline to 12 months

Title

Change in intestinal barrier function

Description

Measured by level of excreted Zonulin in stool samples. A reduction in Zonulin suggests a reduction in intestinal barrier function

Time Frame

Baseline to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan Wolver, MD

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

12. IPD Sharing Statement

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

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