Micellar Curcumin and Metabolic Syndrome Biomarkers

Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome, Protection Against
• Intervention / Treatment: Dietary supplement: Micellar curcumin; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Stuttgart, Baden-Württemberg, Germany, 70599
      • Institute of Biological Chemistry and Nutrition, University of Hohenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Micellar curcumin; 80 mg micellar curcumin (oral) three times a day for six weeks
Placebo Comparator: 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.	Dietary supplement: Placebo; Only the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein (CRP)	Serum CRP in mg/L	At baseline and 6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Collaborators: German Federal Ministry of Education and Research
• Investigators: Principal Investigator: Jan Frank, Ph.D., University of Hohenheim

Publications and helpful links

General Publications

• 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. doi: 10.1002/mnfr.201501034. Epub 2016 May 23.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 23, 2013
• First Submitted That Met QC Criteria: August 15, 2013
• First Posted (Estimate): August 19, 2013

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 0315679-HS3