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Trial record 54 of 167 for:    Curcumin | curcumin

Comparison of Curcumin Bioavailability

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ClinicalTrials.gov Identifier: NCT03530436
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Hohenheim

Tracking Information
First Submitted Date  ICMJE April 25, 2018
First Posted Date  ICMJE May 21, 2018
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE June 7, 2018
Actual Primary Completion Date August 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2018)
  • Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total curcumin after deconjugation with β-glucuronidase
  • Mean area under the curve (AUC) of plasma concentration vs. time of total demethoxycurcumin [nmol/L*h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total demethoxycurcumin after deconjugation with β-glucuronidase
  • Mean area under the curve (AUC) of plasma concentration vs. time of total bisdemethoxycurcumin [nmol/L*h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
  • Maximum plasma concentration (Cmax) of total curcumin [nmol/L] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total curcumin after deconjugation with β-glucuronidase
  • Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total demethoxycurcumin after deconjugation with β-glucuronidase
  • Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
  • Time to reach maximum plasma concentration (Tmax) of total curcumin [h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total curcumin after deconjugation with β-glucuronidase
  • Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total demethoxycurcumin after deconjugation with β-glucuronidase
  • Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
Original Primary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
  • Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total curcumin after deconjugation with β-glucuronidase
  • Mean area under the curve (AUC) of plasma concentration vs. time of total demethoxycurcumin [nmol/L*h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total demethoxycurcumin after deconjugation with β-glucuronidase
  • Mean area under the curve (AUC) of plasma concentration vs. time of total bisdemethoxycurcumin [nmol/L*h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
  • Mean area under the curve (AUC) of plasma concentration vs. time of conjugated curcumin [nmol/L*h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Conjugated curcumin as the difference between total curcumin and curcumin measured without deconjugation with β-glucuronidase
  • Mean area under the curve (AUC) of plasma concentration vs. time of conjugated demethoxycurcumin [nmol/L*h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Conjugated demethoxycurcumin as the difference between total demethoxycurcumin and demethoxycurcumin measured without deconjugation with β-glucuronidase
  • Mean area under the curve (AUC) of plasma concentration vs. time of conjugated bisdemethoxycurcumin [nmol/L*h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Conjugated bisdemethoxycurcumin as the difference between total bisdemethoxycurcumin and bisdemethoxycurcumin measured without deconjugation with β-glucuronidase
  • Maximum plasma concentration (Cmax) of total curcumin [nmol/L] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total curcumin after deconjugation with β-glucuronidase
  • Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total demethoxycurcumin after deconjugation with β-glucuronidase
  • Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
  • Maximum plasma concentration (Cmax) of conjugated curcumin [nmol/L] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Conjugated curcumin as the difference between total curcumin and curcumin measured without deconjugation with β-glucuronidase
  • Maximum plasma concentration (Cmax) of conjugated demethoxycurcumin [nmol/L] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Conjugated demethoxycurcumin as the difference between total demethoxycurcumin and demethoxycurcumin measured without deconjugation with β-glucuronidase
  • Maximum plasma concentration (Cmax) of conjugated bisdemethoxycurcumin [nmol/L] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Conjugated bisdemethoxycurcumin as the difference between total bisdemethoxycurcumin and bisdemethoxycurcumin measured without deconjugation with β-glucuronidase
  • Time to reach maximum plasma concentration (Tmax) of total curcumin [h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total curcumin after deconjugation with β-glucuronidase
  • Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total demethoxycurcumin after deconjugation with β-glucuronidase
  • Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
  • Time to reach maximum plasma concentration (Tmax) of conjugated curcumin [h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Conjugated curcumin as the difference between total curcumin and curcumin measured without deconjugation with β-glucuronidase
  • Time to reach maximum plasma concentration (Tmax) of conjugated demethoxycurcumin [h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Conjugated demethoxycurcumin as the difference between total demethoxycurcumin and demethoxycurcumin measured without deconjugation with β-glucuronidase
  • Time to reach maximum plasma concentration (Tmax) of conjugated bisdemethoxycurcumin [h] [ Time Frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose ]
    Conjugated bisdemethoxycurcumin as the difference between total bisdemethoxycurcumin and bisdemethoxycurcumin measured without deconjugation with β-glucuronidase
Change History Complete list of historical versions of study NCT03530436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Curcumin Bioavailability
Official Title  ICMJE Comparison of the Bioavailability of Different Curcumin Formulations in Healthy Humans
Brief Summary The curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based on its natural low bioavailability and the number of its effects on human health, several approaches such as increasing its water solubility or inhibiting its metabolism were taken to improve its bioavailability. Pharmacokinetics of curcumin from various supplements using those different mechanisms have been compared to the one of native curcumin. The investigator's study here will compare the bioavailability of curcumin from eight different curcumin formulations with native curcumin and between themselves. The study will folllow a single dose (in form of curcumin formulations, normalized to 207 mg curcumin), placebo-controlled, randomized, double-blind, nine-armed crossover study design with ≥ 1-week washout periods. Plasma samples will be collected at intervals up to 24 hours after intake. Investigators will compare the pharmacokinetics between the different curcumin formulations and to native curcumin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Safety After Oral Intake
  • Pharmacokinetics After Oral Intake
Intervention  ICMJE
  • Dietary Supplement: Native turmeric extract
    207 mg curcumin
  • Dietary Supplement: Native turmeric extract with 7-9% volatile turmeric oils
    207 mg curcumin
  • Dietary Supplement: Turmeric extract plus mixture of phytochemicals
    207 mg curcumin
  • Dietary Supplement: Cyclodextrin complex of curcuminoids
    207 mg curcumin
  • Dietary Supplement: Turmeric oleoresin
    207 mg curcumin
  • Dietary Supplement: Liposomal curcumin
    207 mg curcumin
  • Dietary Supplement: Phytosomal curcumin
    207 mg curcumin
  • Dietary Supplement: Micellar turmeric extract
    207 mg curcumin
Study Arms  ICMJE
  • Native turmeric extract
    6 capsules of native curcumin (207 mg curcumin)
    Intervention: Dietary Supplement: Native turmeric extract
  • Experimental: Native turmeric extract with 7-9% volatile turmeric oils
    6 capsules of the formulation; dosage normalized to 207 mg curcumin
    Intervention: Dietary Supplement: Native turmeric extract with 7-9% volatile turmeric oils
  • Experimental: Turmeric extract plus mixture of phytochemicals
    6 capsules of the formulation; dosage normalized to 207 mg curcumin
    Intervention: Dietary Supplement: Turmeric extract plus mixture of phytochemicals
  • Experimental: Cyclodextrin complex of curcuminoids
    6 capsules of the formulation; dosage normalized to 207 mg curcumin
    Intervention: Dietary Supplement: Cyclodextrin complex of curcuminoids
  • Experimental: Turmeric oleoresin
    6 capsules of the formulation; dosage normalized to 207 mg curcumin
    Intervention: Dietary Supplement: Turmeric oleoresin
  • Experimental: Liposomal curcumin
    6 capsules of the formulation; dosage normalized to 207 mg curcumin
    Intervention: Dietary Supplement: Liposomal curcumin
  • Experimental: Phytosomal curcumin
    6 capsules of the formulation; dosage normalized to 207 mg curcumin
    Intervention: Dietary Supplement: Phytosomal curcumin
  • Experimental: Micellar turmeric extract
    6 capsules of the formulation; dosage normalized to 207 mg curcumin
    Intervention: Dietary Supplement: Micellar turmeric extract
Publications * Not Provided

*   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: May 18, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 7, 2018
Actual Primary Completion Date August 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Volunteers with blood chemistry values within normal ranges
  • Body mass index in a normal range

Exclusion Criteria:

  • Pregnancy or lactation
  • Alcohol and or drug abuse
  • Use of dietary supplements or any medications except contraceptives
  • Any known malignant, metabolic and endocrine diseases
  • Previous cardiac infarction
  • Dementia
  • Blood pressure >140/90 mmHg
  • Resting heart rate not within 50 to 90 beats per minute
  • Participation in a clinical trial within the past 6 weeks
  • Smoking
  • Physical activity of more than 5 h per wk
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (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 NCT03530436
Other Study ID Numbers  ICMJE HS-CUV-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Hohenheim
Study Sponsor  ICMJE University of Hohenheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Frank, Prof. Dr. University of Hohenheim
PRS Account University of Hohenheim
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP