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OpenTrials
Completed

NCT Number: NCT01925287

Oral Bioavailability of Curcumin From Micronized Powder and Liquid Micelles in Healthy Young Women and Men

Background: The oral bioavailability of curcumin is low due to its limited intestinal uptake, rapid metabolism and excretion from the body. Considering its potent reported health-beneficial properties, researchers have tried to increase its bioavailability as a means to enhance its biological activities.

Objective: The aim of the project was to develop novel curcumin formulations with enhanced oral bioavailability and to study the safety of the formulations and potential sex-differences in humans.

Design: In this single-blind crossover study with three arms separated by ≥1-week washout periods, healthy subjects (13 women, 10 men) were provided standardized meals and took, in random order, a single oral dose of 500 mg curcumin as native powder, micronized powder, or liquid micelles. Blood and urine samples were collected in intervals for 24 h and total curcumin, demethoxycurcumin, and bis-demethoxycurcumin were quantified.

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Key information

Conditions

Pharmacokinetics of Novel Curcumin Formulations Safety of Novel Curcumin Formulations

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Hohenheim

Stuttgart, 70599, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy volunteers with routine blood chemistry values within the normal ranges

Exclusion criteria

  • overweight (BMI >30 kg/m2)
  • metabolic and endocrine diseases
  • pregnancy
  • lactation
  • drug abuse
  • use of dietary supplements or any form of medication (with the exception of oral contraceptives)
  • smoking
  • frequent alcohol consumption (>20 g ethanol/d)
  • adherence to a restrictive dietary regimen
  • physical activity of more than 5 h/wk
  • participation in a clinical trial within the past 3 months prior to recruitment
  • known intolerance against curcuma

Treatment and study plan

Curcumin

Dietary Supplement

500 mg curcumin were given orally either as native powder, micronized powder, or liquid micelles

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h]

    Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

    Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase

  2. Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h]

    Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

    Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

  3. Area under the plasma concentration versus time curve (AUC) of total bisdemethoxycurcumin [nmol/L*h]

    Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

    Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

  4. Maximum plasma concentration (Cmax) of total curcumin [nmol/L]

    Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

    Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase

  5. Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]

    Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

    Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

  6. Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]

    Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

    Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

  7. Time to reach maximum plasma concentration (Tmax) of total curcumin [h]

    Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

    Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase

  8. Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]

    Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

    Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

  9. Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]

    Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

    Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

Secondary outcomes

  1. Serum aspartate transaminase activity [U/L]

    Time frame: Baseline

  2. Serum aspartate transaminase activity [U/L]

    Time frame: 4 h post-dose

  3. Serum aspartate transaminase activity [U/L]

    Time frame: 24 h post-dose

  4. Serum alanine transaminase activity [U/L]

    Time frame: Baseline

  5. Serum alanine transaminase activity [U/L]

    Time frame: 4 h post-dose

  6. Serum alanine transaminase activity [U/L]

    Time frame: 24 h post-dose

  7. Serum gamma-glutamyl transferase activity [U/L]

    Time frame: Baseline

  8. Serum gamma-glutamyl transferase activity [U/L]

    Time frame: 4 h post-dose

  9. Serum gamma-glutamyl transferase activity [U/L]

    Time frame: 24 h post-dose

  10. Serum alkaline phosphatase activity [U/L]

    Time frame: Baseline

  11. Serum alkaline phosphatase activity [U/L]

    Time frame: 4 h post-dose

  12. Serum alkaline phosphatase activity [U/L]

    Time frame: 24 h post-dose

  13. Serum bilirubin [mg/dL]

    Time frame: Baseline

  14. Serum bilirubin [mg/dL]

    Time frame: 4 h post-dose

  15. Serum bilirubin [mg/dL]

    Time frame: 24 h post-dose

  16. Serum uric acid [mg/dL]

    Time frame: Baseline

  17. Serum uric acid [mg/dL]

    Time frame: 4 h post-dose

  18. Serum uric acid [mg/dL]

    Time frame: 24 h post-dose

  19. Serum cystatin C [mg/L]

    Time frame: Baseline

  20. Serum cystatin C [mg/L]

    Time frame: 4 h post-dose

  21. Serum cystatin C [mg/L]

    Time frame: 24 h post-dose

  22. Glomerular filtration rate [mL/min]

    Time frame: Baseline

  23. Glomerular filtration rate [mL/min]

    Time frame: 4 h post-dose

  24. Glomerular filtration rate [mL/min]

    Time frame: 24 h post-dose

  25. Serum creatinine [mg/dL]

    Time frame: Baseline

  26. Serum creatinine [mg/dL]

    Time frame: 4 h post-dose

  27. Serum creatinine [mg/dL]

    Time frame: 24 h post-dose

  28. Serum total cholesterol [mg/dL]

    Time frame: Baseline

  29. Serum total cholesterol [mg/dL]

    Time frame: 4 h post-dose

  30. Serum total cholesterol [mg/dL]

    Time frame: 24 h post-dose

  31. Serum HDL cholesterol [mg/dL]

    Time frame: Baseline

  32. Serum HDL cholesterol [mg/dL]

    Time frame: 4 h post-dose

  33. Serum HDL cholesterol [mg/dL]

    Time frame: 24 h post-dose

  34. Serum LDL cholesterol [mg/dL]

    Time frame: Baseline

  35. Serum LDL cholesterol [mg/dL]

    Time frame: 4 h post-dose

  36. Serum LDL cholesterol [mg/dL]

    Time frame: 24 h post-dose

  37. Serum triacylglycerols [mg/dL]

    Time frame: Baseline

  38. Serum triacylglycerols [mg/dL]

    Time frame: 4 h post-dose

  39. Serum triacylglycerols [mg/dL]

    Time frame: 24 h post-dose

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

Novel Strategies for the Enhancement of the Potency of Nutraceuticals With Low Oral Bioavailability and Their Application in Novel Functional Foods for Optimum Protection of the Aging Brain

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
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.