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Trial record 39 of 111 for:    Turmeric

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

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.

Condition or disease Intervention/treatment Phase
Safety After Oral Intake Pharmacokinetics After Oral Intake Dietary Supplement: Native turmeric extract Dietary Supplement: Native turmeric extract with 7-9% volatile turmeric oils Dietary Supplement: Turmeric extract plus mixture of phytochemicals Dietary Supplement: Cyclodextrin complex of curcuminoids Dietary Supplement: Turmeric oleoresin Dietary Supplement: Liposomal curcumin Dietary Supplement: Phytosomal curcumin Dietary Supplement: Micellar turmeric extract Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Comparison of the Bioavailability of Different Curcumin Formulations in Healthy Humans
Actual Study Start Date : June 7, 2018
Actual Primary Completion Date : August 10, 2018
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Native turmeric extract
6 capsules of native curcumin (207 mg curcumin)
Dietary Supplement: Native turmeric extract
207 mg curcumin

Experimental: Native turmeric extract with 7-9% volatile turmeric oils
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Native turmeric extract with 7-9% volatile turmeric oils
207 mg curcumin

Experimental: Turmeric extract plus mixture of phytochemicals
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Turmeric extract plus mixture of phytochemicals
207 mg curcumin

Experimental: Cyclodextrin complex of curcuminoids
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Cyclodextrin complex of curcuminoids
207 mg curcumin

Experimental: Turmeric oleoresin
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Turmeric oleoresin
207 mg curcumin

Experimental: Liposomal curcumin
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Liposomal curcumin
207 mg curcumin

Experimental: Phytosomal curcumin
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Phytosomal curcumin
207 mg curcumin

Experimental: Micellar turmeric extract
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Micellar turmeric extract
207 mg curcumin




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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



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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 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

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): NCT03530436


Locations
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Germany
University of Hohenheim
Stuttgart, Baden-Württemberg, Germany, 70599
Sponsors and Collaborators
University of Hohenheim
Investigators
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Principal Investigator: Jan Frank, Prof. Dr. University of Hohenheim

Additional Information:
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Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT03530436     History of Changes
Other Study ID Numbers: HS-CUV-2018
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Hohenheim:
Bioavailability
Pharmacokinetics
Curcumin
Demethoxycurcumin
Bisdemethoxycurcumin

Additional relevant MeSH terms:
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Turmeric extract
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
Antioxidants
Protective Agents