Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study

Not Applicable

Completed

• Conditions: Plasma Levels of Different Curcuminoids Preparations
• Interventions: Dietary Supplement: Curcumin

• Registration Number: NCT05542394
• Lead Sponsor: University of Jordan

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-15
• Study Start: 2022-09-20
• Primary Completion: 2023-04-06
• Study Completion: 2023-04-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-27
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Male and female Apparently healthy adults

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Exclusion Criteria

Postmenopausal women Smokers Overweight Chronic diseases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tumeric with piperine SAP	Curcumin	Turmeric extract standardized to 95% curcuminoids in combination with 5 mg of piperine per capsule will be administered orally (1 dose)
Tumeric without piperine	Curcumin	Turmeric extract standardized to 95% curcuminoids without piperine will be administered orally (1 dose)
Curcumin H2O SAP	Curcumin	Water soluble version of turmeric extract standardized to 10% curcuminoids will be administered orally (1 dose)

Primary Outcome Measures

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

Trial Locations

Locations (1)

The University of Jordan; 🇯🇴 Amman, Jordan