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Trial record 27 of 162 for:    curcumin

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

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ClinicalTrials.gov Identifier: NCT01925287
Recruitment Status : Completed
First Posted : August 19, 2013
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


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

Study Design

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 : October 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013
Arms and Interventions

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


Outcome Measures

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, 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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

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): NCT01925287


Locations
Germany
University of Hohenheim
Stuttgart, 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
More Information

Additional Information:
Publications:
Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT01925287     History of Changes
Other Study ID Numbers: 01EA1334AHS1
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by University of Hohenheim:
bioavailability
curcumin
curcuma longa
healthy humans
safety
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