The University of Jordan
Amman, Jordan
Completed
NCT Number: NCT05542394
Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study
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.
Completed
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Notify MeKey information
Age range
18 year–25 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Male and female Apparently healthy adults
Exclusion criteria
Postmenopausal women Smokers Overweight Chronic diseases
Treatment and study plan
Curcumin
Dietary Supplementwater soluble version of turmeric extract standardized to 10% curcuminoids
.
Other names: NFH
Primary outcomes
-
Blood concentration of bisdemethoxycurcumin
Time frame: [Time Frame: Change during 8 hours]
plasma bisdemethoxycurcumin levels using LC MS/MS
-
Blood concentration of desmethoxycurcumin
Time frame: [Time Frame: Change during 8 hours]
plasma desmethoxycurcumin levels using LC MS/MS
-
Blood concentration of piperine-curcuminoids
Time frame: [Time Frame: Change during 8 hours]
plasma piperine-curcuminoids levels using LC MS/MS
-
Blood concentration of hexahydrocurcumin
Time frame: [Time Frame: Change during 8 hours]
plasma hexahydrocurcumin levels using LC MS/MS
-
Blood concentration of curcumin diethyl disuccinate
Time frame: [Time Frame: Change during 8 hours]
plasma curcumin diethyl disuccinate levels using LC MS/MS
-
Blood concentration of tetrahydrocurcumin
Time frame: [Time Frame: Change during 8 hours]
plasma tetrahydrocurcumin levels using LC MS/MS
-
Blood concentration of curcumin
Time frame: [Time Frame: Change during 8 hours]
plasma curcumin levels using LC MS/MS
Sponsors and collaborators
Lead sponsor
University of Jordan
Other
Collaborators
- Nutritional Fundamentals for Health
Registry information
Important dates
- Study start
- 2022
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Sep 15, 2022
- Registry last updated
- Aug 29, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.