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Trial record 32 of 168 for:    curcumin

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

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics of New Curcumin Formulations Safety of New Curcumin Formulations Dietary Supplement: curcumin Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official 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
Study Start Date : November 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Active Comparator: Native curcumin
80 mg curcumin as native powder
Dietary Supplement: curcumin
80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals
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
Dietary Supplement: curcumin
80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals
Experimental: Curcumin micelles
80 mg curcumin incorporated into liquid micelles
Dietary Supplement: curcumin
80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals
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
Dietary Supplement: curcumin
80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01982734


Locations
Germany
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, Stuttgart, Germany

Additional Information:
Publications of Results:
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.

Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT01982734     History of Changes
Other Study ID Numbers: 051113-HS2
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by University of Hohenheim:
bioavailability
curcumin
pharmacokinetic
curcuma longa
age differences
sex differences

Additional relevant MeSH terms:
Curcumin
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