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Completed

NCT Number: NCT01925547

Micellar Curcumin and Metabolic Syndrome Biomarkers

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.

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Key information

Conditions

Metabolic Syndrome, Protection Against Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Biological Chemistry and Nutrition, University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micellar curcumin

Dietary Supplement

80 mg micellar curcumin (oral) three times a day for six weeks

Placebo

Dietary Supplement

Only the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo.

Primary outcomes

  1. C-reactive protein (CRP)

    Time frame: At baseline and 6 weeks

    Serum CRP in mg/L

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 19, 2013
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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