Clinical trial NCT05542394: Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study
Official title: Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plasma Levels of Different Curcuminoids Preparations
Keywords: Curcumin H2O, Tumeric, piperine
Lead sponsor: University of Jordan
Sponsor class: OTHER
Collaborators: name: Nutritional Fundamentals for Health
First posted: 2022-09-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

Male and female Apparently healthy adults

Exclusion Criteria:

Postmenopausal women Smokers Overweight Chronic diseases

Primary outcomes:
measure: Blood concentration of bisdemethoxycurcumin
timeFrame: [Time Frame: Change during 8 hours]
measure: Blood concentration of desmethoxycurcumin
timeFrame: [Time Frame: Change during 8 hours]
measure: Blood concentration of piperine-curcuminoids
timeFrame: [Time Frame: Change during 8 hours]
measure: Blood concentration of hexahydrocurcumin
timeFrame: [Time Frame: Change during 8 hours]
measure: Blood concentration of curcumin diethyl disuccinate
timeFrame: [Time Frame: Change during 8 hours]
measure: Blood concentration of tetrahydrocurcumin
timeFrame: [Time Frame: Change during 8 hours]
measure: Blood concentration of curcumin
timeFrame: [Time Frame: Change during 8 hours]
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: The University of Jordan
Study officials:
References:
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