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OpenTrials
Completed

NCT Number: NCT01982734

Improved Oral Bioavailability of Curcumin Incorporated Into Micelles

Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous health-promoting activities. The oral bioavailability of curcumin is low due to its poor aqueous solubility, limited gastrointestinal absorption, rapid metabolism and excretion. Therefore, we tested, in a randomized crossover study, simultaneous application of phytochemicals and micellar solubilisation, alone and together, as strategies to enhance the absorption of curcumin into the body. Furthermore, we investigated age and sex differences in curcumin pharmacokinetics.

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Key information

Conditions

Pharmacokinetics of New Curcumin Formulations Safety of New Curcumin Formulations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Hohenheim

Stuttgart, Baden-Wurttemberg, 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
  • Age: 18-35 years or > 60 years

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

Treatment and study plan

Curcumin

Dietary Supplement

80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals

Primary outcomes

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

    Time frame: 0, 0.5, 1, 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, 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, 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, 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, 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, 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, 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, 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, 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: 0, 4, 24h post-dose

  2. Serum alanine transaminase activity [U/L]

    Time frame: 0, 4, 24h post-dose

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

    Time frame: 0, 4, 24h post-dose

  4. Serum alkaline phosphatase activity [U/L]

    Time frame: 0, 4, 24h post-dose

  5. Serum bilirubin [mg/dL]

    Time frame: 0, 4, 24h post-dose

  6. Serum uric acid [mg/dL]

    Time frame: 0, 4, 24h post-dose

  7. Serum creatinine [mg/dL]

    Time frame: 0, 4, 24h post-dose

  8. Serum total cholesterol [mg/dL]

    Time frame: 0, 4, 24h post-dose

  9. Serum HDL cholesterol [mg/dL]

    Time frame: 0, 4, 24h post-dose

  10. Serum LDL cholesterol [mg/dL]

    Time frame: 0, 4, 24h post-dose

  11. Serum triacylglycerols [mg/dL]

    Time frame: 0, 4, 24h 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
2012
Primary completion
2013
Study completion
2013
First posted
Nov 13, 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.