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Trial record 44 of 162 for:    curcumin

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:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome, Protection Against Dietary Supplement: Micellar curcumin Dietary Supplement: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers
Study Start Date : July 2013
Primary Completion Date : March 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. C-reactive protein (CRP) [ Time Frame: At baseline and 6 weeks ]
    Serum CRP in mg/L


Secondary Outcome Measures :
  1. Plasma curcumin concentrations [ Time Frame: At baseline and 6 weeks ]
    Concentrations (in nmol/L) of curcumin and curcumin conjugates in plasma

  2. Serum alanine transaminase activity [ Time Frame: At baseline and 6 weeks ]
    Serum activity of ALT in U/L

  3. Fasting blood glucose [ Time Frame: At baseline and 6 weeks ]
    Fasting blood glucose in mmol/L

  4. Plasma tumor necrosis factor alpha [ Time Frame: At baseline and 6 weeks ]
    Plasma concentrations of TNFα in pg/mL

  5. Serum uric acid [ Time Frame: At baseline and 6 weeks ]
    Serum concentrations of uric acid in g/L

  6. Plasma albumin [ Time Frame: At baseline and 6 weeks ]
    Plasma concentrations of albumin in g/L

  7. Serum total cholesterol [ Time Frame: At baseline and 6 weeks ]
    Serum total cholesterol in mmol/L

  8. Serum triacylglycerols [ Time Frame: At baseline and 6 weeks ]
    Serum triacylglycerols in mmol/L

  9. Serum HDL cholesterol [ Time Frame: At baseline and 6 weeks ]
    Serum HDL cholesterol in mmol/L

  10. Serum LDL cholesterol [ Time Frame: At baseline and 6 weeks ]
    Serum LDL cholesterol in mmol/L

  11. Serum aspartate transaminase activity [ Time Frame: At baseline and 6 weeks ]
    Serum activity of AST in U/L

  12. Serum gamma glutamyl transferase activity [ Time Frame: At baseline and 6 weeks ]
    Serum activity of gamma-GT in U/L

  13. Serum alkaline phosphatase activity [ Time Frame: At baseline and 6 weeks ]
    Serum activity of ALP in U/L

  14. Serum bilirubin [ Time Frame: At baseline and 6 weeks ]
    Serum concentrations of bilirubin in g/L

  15. Plasma interleukine 6 [ Time Frame: At baseline and 6 weeks ]
    Plasma concentrations of IL-6 in pg/mL

  16. Serum insulin [ Time Frame: At baseline and 6 weeks ]
    Serum concentrations of insulin in pg/mL

  17. Body weight [ Time Frame: At baseline and 6 weeks ]
    Body weight in kg

  18. Diastolic blood pressure [ Time Frame: At baseline and 6 weeks ]
    Diastolic blood pressure in mmHg

  19. Serum creatinine [ Time Frame: At baseline and 6 weeks ]
    Serum concentrations of creatinine in g/L

  20. Systolic blood pressure [ Time Frame: At baseline and 6 weeks ]
    Systolic blood pressure in mmHg


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925547


Locations
Germany
Institute of Biological Chemistry and Nutrition, University of Hohenheim
Stuttgart, Baden-Württemberg, Germany, 70599
Sponsors and Collaborators
University of Hohenheim
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Jan Frank, Ph.D. University of Hohenheim
More Information

Publications:
Responsible Party: Jan Frank, Professor, Ph.D., University of Hohenheim
ClinicalTrials.gov Identifier: NCT01925547     History of Changes
Other Study ID Numbers: 0315679-HS3
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Curcumin
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action