Micellar Curcumin and Metabolic Syndrome Biomarkers

Metabolic Syndrome, Protection Against Clinical Trial

Official title:

Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925547
• Other study ID #: 0315679-HS3
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2013
• Last updated: October 24, 2016
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2016
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Total cholesterol > 5.2 mmol/L

• LDL cholesterol > 3.4 mmol/L

• Triglyceride > 2.26 mmol/L

• CRP > 2 mg/L

Exclusion criteria:

• Intake of drugs or dietary supplements

• Pregnant women and breastfeeding mothers

• Smokers

• Previous illnesses such as heart attack, cancer or dementia

• Addiction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Metabolic Syndrome, Protection Against
• Syndrome

Intervention

Dietary Supplement:
• Micellar curcumin
80 mg micellar curcumin (oral) three times a day for six weeks
• Placebo
Only the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo.

Locations

Country	Name	City	State
Germany	Institute of Biological Chemistry and Nutrition, University of Hohenheim	Stuttgart	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Hohenheim	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kocher A, Bohnert L, Schiborr C, Frank J. Highly bioavailable micellar curcuminoids accumulate in blood, are safe and do not reduce blood lipids and inflammation markers in moderately hyperlipidemic individuals. Mol Nutr Food Res. 2016 Jul;60(7):1555-63. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive protein (CRP)	Serum CRP in mg/L	At baseline and 6 weeks	No
Secondary	Plasma curcumin concentrations	Concentrations (in nmol/L) of curcumin and curcumin conjugates in plasma	At baseline and 6 weeks	No
Secondary	Serum alanine transaminase activity	Serum activity of ALT in U/L	At baseline and 6 weeks	Yes
Secondary	Fasting blood glucose	Fasting blood glucose in mmol/L	At baseline and 6 weeks	No
Secondary	Plasma tumor necrosis factor alpha	Plasma concentrations of TNFa in pg/mL	At baseline and 6 weeks	No
Secondary	Serum uric acid	Serum concentrations of uric acid in g/L	At baseline and 6 weeks	Yes
Secondary	Plasma albumin	Plasma concentrations of albumin in g/L	At baseline and 6 weeks	Yes
Secondary	Serum total cholesterol	Serum total cholesterol in mmol/L	At baseline and 6 weeks	No
Secondary	Serum triacylglycerols	Serum triacylglycerols in mmol/L	At baseline and 6 weeks	No
Secondary	Serum HDL cholesterol	Serum HDL cholesterol in mmol/L	At baseline and 6 weeks	No
Secondary	Serum LDL cholesterol	Serum LDL cholesterol in mmol/L	At baseline and 6 weeks	No
Secondary	Serum aspartate transaminase activity	Serum activity of AST in U/L	At baseline and 6 weeks	Yes
Secondary	Serum gamma glutamyl transferase activity	Serum activity of gamma-GT in U/L	At baseline and 6 weeks	Yes
Secondary	Serum alkaline phosphatase activity	Serum activity of ALP in U/L	At baseline and 6 weeks	Yes
Secondary	Serum bilirubin	Serum concentrations of bilirubin in g/L	At baseline and 6 weeks	Yes
Secondary	Plasma interleukine 6	Plasma concentrations of IL-6 in pg/mL	At baseline and 6 weeks	No
Secondary	Serum insulin	Serum concentrations of insulin in pg/mL	At baseline and 6 weeks	No
Secondary	Body weight	Body weight in kg	At baseline and 6 weeks	No
Secondary	Diastolic blood pressure	Diastolic blood pressure in mmHg	At baseline and 6 weeks	No
Secondary	Serum creatinine	Serum concentrations of creatinine in g/L	At baseline and 6 weeks	Yes
Secondary	Systolic blood pressure	Systolic blood pressure in mmHg	At baseline and 6 weeks	No