Comparison of Curcumin Bioavailability

NCT ID: NCT03530436

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-07

Study Completion Date

2018-11-07

Brief Summary

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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

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Conditions

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Safety After Oral Intake Pharmacokinetics After Oral Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Native turmeric extract

6 capsules of native curcumin (207 mg curcumin)

Group Type OTHER

Native turmeric extract

Intervention Type DIETARY_SUPPLEMENT

207 mg curcumin

Native turmeric extract with 7-9% volatile turmeric oils

6 capsules of the formulation; dosage normalized to 207 mg curcumin

Group Type EXPERIMENTAL

Native turmeric extract with 7-9% volatile turmeric oils

Intervention Type DIETARY_SUPPLEMENT

207 mg curcumin

Turmeric extract plus mixture of phytochemicals

6 capsules of the formulation; dosage normalized to 207 mg curcumin

Group Type EXPERIMENTAL

Turmeric extract plus mixture of phytochemicals

Intervention Type DIETARY_SUPPLEMENT

207 mg curcumin

Cyclodextrin complex of curcuminoids

6 capsules of the formulation; dosage normalized to 207 mg curcumin

Group Type EXPERIMENTAL

Cyclodextrin complex of curcuminoids

Intervention Type DIETARY_SUPPLEMENT

207 mg curcumin

Turmeric oleoresin

6 capsules of the formulation; dosage normalized to 207 mg curcumin

Group Type EXPERIMENTAL

Turmeric oleoresin

Intervention Type DIETARY_SUPPLEMENT

207 mg curcumin

Liposomal curcumin

6 capsules of the formulation; dosage normalized to 207 mg curcumin

Group Type EXPERIMENTAL

Liposomal curcumin

Intervention Type DIETARY_SUPPLEMENT

207 mg curcumin

Phytosomal curcumin

6 capsules of the formulation; dosage normalized to 207 mg curcumin

Group Type EXPERIMENTAL

Phytosomal curcumin

Intervention Type DIETARY_SUPPLEMENT

207 mg curcumin

Micellar turmeric extract

6 capsules of the formulation; dosage normalized to 207 mg curcumin

Group Type EXPERIMENTAL

Micellar turmeric extract

Intervention Type DIETARY_SUPPLEMENT

207 mg curcumin

Interventions

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Native turmeric extract

207 mg curcumin

Intervention Type DIETARY_SUPPLEMENT

Native turmeric extract with 7-9% volatile turmeric oils

207 mg curcumin

Intervention Type DIETARY_SUPPLEMENT

Turmeric extract plus mixture of phytochemicals

207 mg curcumin

Intervention Type DIETARY_SUPPLEMENT

Cyclodextrin complex of curcuminoids

207 mg curcumin

Intervention Type DIETARY_SUPPLEMENT

Turmeric oleoresin

207 mg curcumin

Intervention Type DIETARY_SUPPLEMENT

Liposomal curcumin

207 mg curcumin

Intervention Type DIETARY_SUPPLEMENT

Phytosomal curcumin

207 mg curcumin

Intervention Type DIETARY_SUPPLEMENT

Micellar turmeric extract

207 mg curcumin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Frank, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim

Locations

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University of Hohenheim

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Related Links

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http://www.nutrition-research.de/

Website of the research group

Other Identifiers

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HS-CUV-2018

Identifier Type: -

Identifier Source: org_study_id

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