Clinical trial NCT03542240: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
High Blood Pressure
High Cholesterol
Type2 Diabetes
Heart Diseases
Keywords: curcumin
microbiome
dietary supplements
gut bacteria
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Change inintestinal permeability
timeFrame: Baseline to 12 months
measure: Change in intestinal barrier function
timeFrame: Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Susan Wolver, MD
role: PRINCIPAL_INVESTIGATOR
References: