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

October 24, 2016 updated by: University of Hohenheim

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany, 70599
        • University of Hohenheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
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
0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
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
0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
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
0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
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
0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
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
0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
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
0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
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
0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose
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
0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum aspartate transaminase activity [U/L]
Time Frame: Baseline
Baseline
Serum aspartate transaminase activity [U/L]
Time Frame: 4 h post-dose
4 h post-dose
Serum aspartate transaminase activity [U/L]
Time Frame: 24 h post-dose
24 h post-dose
Serum alanine transaminase activity [U/L]
Time Frame: Baseline
Baseline
Serum alanine transaminase activity [U/L]
Time Frame: 4 h post-dose
4 h post-dose
Serum alanine transaminase activity [U/L]
Time Frame: 24 h post-dose
24 h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time Frame: Baseline
Baseline
Serum gamma-glutamyl transferase activity [U/L]
Time Frame: 4 h post-dose
4 h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time Frame: 24 h post-dose
24 h post-dose
Serum alkaline phosphatase activity [U/L]
Time Frame: Baseline
Baseline
Serum alkaline phosphatase activity [U/L]
Time Frame: 4 h post-dose
4 h post-dose
Serum alkaline phosphatase activity [U/L]
Time Frame: 24 h post-dose
24 h post-dose
Serum bilirubin [mg/dL]
Time Frame: Baseline
Baseline
Serum bilirubin [mg/dL]
Time Frame: 4 h post-dose
4 h post-dose
Serum bilirubin [mg/dL]
Time Frame: 24 h post-dose
24 h post-dose
Serum uric acid [mg/dL]
Time Frame: Baseline
Baseline
Serum uric acid [mg/dL]
Time Frame: 4 h post-dose
4 h post-dose
Serum uric acid [mg/dL]
Time Frame: 24 h post-dose
24 h post-dose
Serum cystatin C [mg/L]
Time Frame: Baseline
Baseline
Serum cystatin C [mg/L]
Time Frame: 4 h post-dose
4 h post-dose
Serum cystatin C [mg/L]
Time Frame: 24 h post-dose
24 h post-dose
Glomerular filtration rate [mL/min]
Time Frame: Baseline
Baseline
Glomerular filtration rate [mL/min]
Time Frame: 4 h post-dose
4 h post-dose
Glomerular filtration rate [mL/min]
Time Frame: 24 h post-dose
24 h post-dose
Serum creatinine [mg/dL]
Time Frame: Baseline
Baseline
Serum creatinine [mg/dL]
Time Frame: 4 h post-dose
4 h post-dose
Serum creatinine [mg/dL]
Time Frame: 24 h post-dose
24 h post-dose
Serum total cholesterol [mg/dL]
Time Frame: Baseline
Baseline
Serum total cholesterol [mg/dL]
Time Frame: 4 h post-dose
4 h post-dose
Serum total cholesterol [mg/dL]
Time Frame: 24 h post-dose
24 h post-dose
Serum HDL cholesterol [mg/dL]
Time Frame: Baseline
Baseline
Serum HDL cholesterol [mg/dL]
Time Frame: 4 h post-dose
4 h post-dose
Serum HDL cholesterol [mg/dL]
Time Frame: 24 h post-dose
24 h post-dose
Serum LDL cholesterol [mg/dL]
Time Frame: Baseline
Baseline
Serum LDL cholesterol [mg/dL]
Time Frame: 4 h post-dose
4 h post-dose
Serum LDL cholesterol [mg/dL]
Time Frame: 24 h post-dose
24 h post-dose
Serum triacylglycerols [mg/dL]
Time Frame: Baseline
Baseline
Serum triacylglycerols [mg/dL]
Time Frame: 4 h post-dose
4 h post-dose
Serum triacylglycerols [mg/dL]
Time Frame: 24 h post-dose
24 h post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Hohenheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Federal Ministry of Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01EA1334AHS1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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