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Micellar Curcumin and Metabolic Syndrome Biomarkers

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ClinicalTrials.gov Identifier: NCT01925547
Recruitment Status : Completed
First Posted : August 19, 2013
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Jan Frank, University of Hohenheim

Tracking Information
First Submitted Date  ICMJE July 23, 2013
First Posted Date  ICMJE August 19, 2013
Last Update Posted Date October 25, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2013)
C-reactive protein (CRP) [ Time Frame: At baseline and 6 weeks ]
Serum CRP in mg/L
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01925547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2013)
  • Plasma curcumin concentrations [ Time Frame: At baseline and 6 weeks ]
    Concentrations (in nmol/L) of curcumin and curcumin conjugates in plasma
  • Serum alanine transaminase activity [ Time Frame: At baseline and 6 weeks ]
    Serum activity of ALT in U/L
  • Fasting blood glucose [ Time Frame: At baseline and 6 weeks ]
    Fasting blood glucose in mmol/L
  • Plasma tumor necrosis factor alpha [ Time Frame: At baseline and 6 weeks ]
    Plasma concentrations of TNFα in pg/mL
  • Serum uric acid [ Time Frame: At baseline and 6 weeks ]
    Serum concentrations of uric acid in g/L
  • Plasma albumin [ Time Frame: At baseline and 6 weeks ]
    Plasma concentrations of albumin in g/L
  • Serum total cholesterol [ Time Frame: At baseline and 6 weeks ]
    Serum total cholesterol in mmol/L
  • Serum triacylglycerols [ Time Frame: At baseline and 6 weeks ]
    Serum triacylglycerols in mmol/L
  • Serum HDL cholesterol [ Time Frame: At baseline and 6 weeks ]
    Serum HDL cholesterol in mmol/L
  • Serum LDL cholesterol [ Time Frame: At baseline and 6 weeks ]
    Serum LDL cholesterol in mmol/L
  • Serum aspartate transaminase activity [ Time Frame: At baseline and 6 weeks ]
    Serum activity of AST in U/L
  • Serum gamma glutamyl transferase activity [ Time Frame: At baseline and 6 weeks ]
    Serum activity of gamma-GT in U/L
  • Serum alkaline phosphatase activity [ Time Frame: At baseline and 6 weeks ]
    Serum activity of ALP in U/L
  • Serum bilirubin [ Time Frame: At baseline and 6 weeks ]
    Serum concentrations of bilirubin in g/L
  • Plasma interleukine 6 [ Time Frame: At baseline and 6 weeks ]
    Plasma concentrations of IL-6 in pg/mL
  • Serum insulin [ Time Frame: At baseline and 6 weeks ]
    Serum concentrations of insulin in pg/mL
  • Body weight [ Time Frame: At baseline and 6 weeks ]
    Body weight in kg
  • Diastolic blood pressure [ Time Frame: At baseline and 6 weeks ]
    Diastolic blood pressure in mmHg
  • Serum creatinine [ Time Frame: At baseline and 6 weeks ]
    Serum concentrations of creatinine in g/L
  • Systolic blood pressure [ Time Frame: At baseline and 6 weeks ]
    Systolic blood pressure in mmHg
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Micellar Curcumin and Metabolic Syndrome Biomarkers
Official Title  ICMJE Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome, Protection Against
Intervention  ICMJE
  • Dietary Supplement: Micellar curcumin
    80 mg micellar curcumin (oral) three times a day for six weeks
  • Dietary Supplement: Placebo
    Only the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Micellar curcumin
  • 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.
    Intervention: Dietary Supplement: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2014)
42
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2013)
48
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01925547
Other Study ID Numbers  ICMJE 0315679-HS3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jan Frank, University of Hohenheim
Study Sponsor  ICMJE University of Hohenheim
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE
Principal Investigator: Jan Frank, Ph.D. University of Hohenheim
PRS Account University of Hohenheim
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP