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Improved Oral Bioavailability of Curcumin Incorporated Into Micelles

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ClinicalTrials.gov Identifier: NCT01982734
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
University of Hohenheim

Tracking Information
First Submitted Date  ICMJE November 5, 2013
First Posted Date  ICMJE November 13, 2013
Last Update Posted Date October 25, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01982734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
  • Serum aspartate transaminase activity [U/L] [ Time Frame: 0, 4, 24h post-dose ]
  • Serum alanine transaminase activity [U/L] [ Time Frame: 0, 4, 24h post-dose ]
  • Serum gamma-glutamyl transferase activity [U/L] [ Time Frame: 0, 4, 24h post-dose ]
  • Serum alkaline phosphatase activity [U/L] [ Time Frame: 0, 4, 24h post-dose ]
  • Serum bilirubin [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  • Serum uric acid [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  • Serum creatinine [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  • Serum total cholesterol [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  • Serum HDL cholesterol [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  • Serum LDL cholesterol [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
  • Serum triacylglycerols [mg/dL] [ Time Frame: 0, 4, 24h post-dose ]
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 Improved Oral Bioavailability of Curcumin Incorporated Into Micelles
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Pharmacokinetics of New Curcumin Formulations
  • Safety of New Curcumin Formulations
Intervention  ICMJE Dietary Supplement: curcumin
80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals
Study Arms  ICMJE
  • Active Comparator: Native curcumin
    80 mg curcumin as native powder
    Intervention: Dietary Supplement: curcumin
  • Experimental: Native curcumin plus phytochemicals
    80 mg curcumin as native powder plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid and 40 mg xanthohumol
    Intervention: Dietary Supplement: curcumin
  • Experimental: Curcumin micelles
    80 mg curcumin incorporated into liquid micelles
    Intervention: Dietary Supplement: curcumin
  • Experimental: Curcumin micelles plus phytochemicals
    80 mg curcumin incorporated into liquid micelles plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid, 40 mg xanthohumol incorporated into micelles
    Intervention: Dietary Supplement: curcumin
Publications * Kocher, A., Schiborr, C., Behnam, D., & Frank, J. (2015). The oral bioavailability of curcuminoids in healthy humans is markedly enhanced by micellar solubilisation but not further improved by simultaneous ingestion of sesamin, ferulic acid, naringenin and xanthohumol. J Funct Foods 14: 183-19.

*   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: November 5, 2013)
23
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01982734
Other Study ID Numbers  ICMJE 051113-HS2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party 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, Stuttgart, Germany
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