Micellar Curcumin and Metabolic Syndrome Biomarkers

Phase 2

Completed

• Conditions: Metabolic Syndrome, Protection Against
• Interventions: Dietary Supplement: Micellar curcumin; Dietary Supplement: Placebo

• Registration Number: NCT01925547
• Lead Sponsor: University of Hohenheim

Brief Summary

The purpose of this study is to investigate the effect of micellar curcumin on inflammation and lipid metabolism markers in subjects at risk for the metabolic syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-19
• Primary Completion: 2014-03
• Study Completion: 2014-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Micellar curcumin	Micellar curcumin	Subjects receive three times per day four capsules of curcumin micelles. One capsule contains 20 mg of curcumin. At the beginning, after three and six weeks of intake, blood samples are collected.
Placebo	Placebo	Subjects receive three times per day four capsules of placebo preparation. At the beginning, after three and six weeks of intake, blood samples are collected.

Primary Outcome Measures

Name	Time	Method
C-reactive protein (CRP)	At baseline and 6 weeks	Serum CRP in mg/L

Secondary Outcome Measures

Name	Time	Method
Plasma curcumin concentrations	At baseline and 6 weeks	Concentrations (in nmol/L) of curcumin and curcumin conjugates in plasma
Serum total cholesterol	At baseline and 6 weeks	Serum total cholesterol in mmol/L
Serum HDL cholesterol	At baseline and 6 weeks	Serum HDL cholesterol in mmol/L
Serum LDL cholesterol	At baseline and 6 weeks	Serum LDL cholesterol in mmol/L
Serum aspartate transaminase activity	At baseline and 6 weeks	Serum activity of AST in U/L
Plasma interleukine 6	At baseline and 6 weeks	Plasma concentrations of IL-6 in pg/mL
Body weight	At baseline and 6 weeks	Body weight in kg
Serum alanine transaminase activity	At baseline and 6 weeks	Serum activity of ALT in U/L
Fasting blood glucose	At baseline and 6 weeks	Fasting blood glucose in mmol/L
Serum insulin	At baseline and 6 weeks	Serum concentrations of insulin in pg/mL
Systolic blood pressure	At baseline and 6 weeks	Systolic blood pressure in mmHg
Serum uric acid	At baseline and 6 weeks	Serum concentrations of uric acid in g/L
Serum triacylglycerols	At baseline and 6 weeks	Serum triacylglycerols in mmol/L
Serum gamma glutamyl transferase activity	At baseline and 6 weeks	Serum activity of gamma-GT in U/L
Serum alkaline phosphatase activity	At baseline and 6 weeks	Serum activity of ALP in U/L
Diastolic blood pressure	At baseline and 6 weeks	Diastolic blood pressure in mmHg
Plasma tumor necrosis factor alpha	At baseline and 6 weeks	Plasma concentrations of TNFα in pg/mL
Plasma albumin	At baseline and 6 weeks	Plasma concentrations of albumin in g/L
Serum bilirubin	At baseline and 6 weeks	Serum concentrations of bilirubin in g/L
Serum creatinine	At baseline and 6 weeks	Serum concentrations of creatinine in g/L

Trial Locations

Locations (1)

Institute of Biological Chemistry and Nutrition, University of Hohenheim; 🇩🇪 Stuttgart, Baden-Württemberg, Germany