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Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study

Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05542394
Enrollment
24
Registered
2022-09-15
Start date
2022-09-20
Completion date
2023-04-30
Last updated
2023-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasma Levels of Different Curcuminoids Preparations

Keywords

Curcumin H2O, Tumeric, piperine

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.

Interventions

DIETARY_SUPPLEMENTCurcumin

water soluble version of turmeric extract standardized to 10% curcuminoids .

Sponsors

Nutritional Fundamentals for Health
CollaboratorUNKNOWN
University of Jordan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

Male and female Apparently healthy adults

Exclusion criteria

Postmenopausal women Smokers Overweight Chronic diseases

Design outcomes

Primary

MeasureTime frameDescription
Blood concentration of bisdemethoxycurcumin[Time Frame: Change during 8 hours]plasma bisdemethoxycurcumin 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 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 tetrahydrocurcumin[Time Frame: Change during 8 hours]plasma tetrahydrocurcumin levels using LC MS/MS
Blood concentration of curcumin[Time Frame: Change during 8 hours]plasma curcumin levels using LC MS/MS

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026