Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study

August 27, 2023 updated by: Shatha Hammad, Assistant Professor, University of Jordan
This pilot study aims to investigate the pharmacokinetics of a novel curcuminoid preparation with suggested high bioavailability due to its solubility in water, compared to two standard hydrophobic formulations. The findings of this study will help the health care providers and community to select suitable formulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pilot study is the first phase that must be followed, in the second phase, by longer clinical trials to support the findings and investigate the role of the novel preparation on health.The second phase will include an assessment of the effectiveness of several doses of curcumin preparation on health as well as an evaluation of the tolerance and possible adverse effects. The latter could not be evaluated at this stage of a single dose.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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

  • Jordan
      • Amman, Jordan
        • The University of Jordan

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

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Male and female Apparently healthy adults

Exclusion Criteria:

Postmenopausal women Smokers Overweight Chronic diseases

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Curcumin H2O SAP
Water soluble version of turmeric extract standardized to 10% curcuminoids will be administered orally (1 dose)
Dietary supplement: Curcumin

water soluble version of turmeric extract standardized to 10% curcuminoids

.

Other Names:
  • NFH
Active Comparator: Tumeric with piperine SAP
Turmeric extract standardized to 95% curcuminoids in combination with 5 mg of piperine per capsule will be administered orally (1 dose)
Dietary supplement: Curcumin

water soluble version of turmeric extract standardized to 10% curcuminoids

.

Other Names:
  • NFH
Placebo Comparator: Tumeric without piperine
Turmeric extract standardized to 95% curcuminoids without piperine will be administered orally (1 dose)
Dietary supplement: Curcumin

water soluble version of turmeric extract standardized to 10% curcuminoids

.

Other Names:
  • NFH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood concentration of bisdemethoxycurcumin
Time Frame: [Time Frame: Change during 8 hours]
plasma bisdemethoxycurcumin levels using LC MS/MS
[Time Frame: Change during 8 hours]
Blood concentration of desmethoxycurcumin
Time Frame: [Time Frame: Change during 8 hours]
plasma desmethoxycurcumin levels using LC MS/MS
[Time Frame: Change during 8 hours]
Blood concentration of piperine-curcuminoids
Time Frame: [Time Frame: Change during 8 hours]
plasma piperine-curcuminoids levels using LC MS/MS
[Time Frame: Change during 8 hours]
Blood concentration of hexahydrocurcumin
Time Frame: [Time Frame: Change during 8 hours]
plasma hexahydrocurcumin levels using LC MS/MS
[Time Frame: Change during 8 hours]
Blood concentration of curcumin diethyl disuccinate
Time Frame: [Time Frame: Change during 8 hours]
plasma curcumin diethyl disuccinate levels using LC MS/MS
[Time Frame: Change during 8 hours]
Blood concentration of tetrahydrocurcumin
Time Frame: [Time Frame: Change during 8 hours]
plasma tetrahydrocurcumin levels using LC MS/MS
[Time Frame: Change during 8 hours]
Blood concentration of curcumin
Time Frame: [Time Frame: Change during 8 hours]
plasma curcumin levels using LC MS/MS
[Time Frame: Change during 8 hours]

Collaborators and Investigators

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

Sponsor

University of Jordan

Collaborators

Nutritional Fundamentals for Health

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

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 (Actual)

September 20, 2022

Primary Completion (Actual)

April 6, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-2022/13342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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