Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study

Conditions
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Plasma Levels of Different Curcuminoids Preparations

Intervention / Treatment
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* Dietary Supplement: Curcumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female Apparently healthy adults Exclusion Criteria: Postmenopausal women Smokers Overweight Chronic diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin H2O SAP<br>Water soluble version of turmeric extract standardized to 10% curcuminoids will be administered orally (1 dose) | Dietary Supplement: Curcumin<br>* water soluble version of turmeric extract standardized to 10% curcuminoids .<br>* Other names: NFH;|
| Active Comparator: Tumeric with piperine SAP<br>Turmeric extract standardized to 95% curcuminoids in combination with 5 mg of piperine per capsule will be administered orally (1 dose) | Dietary Supplement: Curcumin<br>* water soluble version of turmeric extract standardized to 10% curcuminoids .<br>* Other names: NFH;|
| Placebo Comparator: Tumeric without piperine<br>Turmeric extract standardized to 95% curcuminoids without piperine will be administered orally (1 dose) | Dietary Supplement: Curcumin<br>* water soluble version of turmeric extract standardized to 10% curcuminoids .<br>* Other names: NFH;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curcumin H2O, Tumeric, piperine