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

NCT ID: NCT03542240

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2020-11-13

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Curcumin

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DIETARY_SUPPLEMENT

500 milligram daily supplement

Interventions

Curcumin

500 milligram daily supplement

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Wolver, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20012060

Identifier Type: -

Identifier Source: org_study_id