Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study

University of Jordan

Status: Completed

Conditions: Plasma Levels of Different Curcuminoids Preparations

Treatments: Dietary Supplement: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT05542394

10-2022/13342

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Male and female Apparently healthy adults

Exclusion criteria

Postmenopausal women Smokers Overweight Chronic diseases

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

Curcumin H2O SAP

Experimental group

Description:

Water soluble version of turmeric extract standardized to 10% curcuminoids will be administered orally (1 dose)

Treatment:

Dietary Supplement: Curcumin

Tumeric with piperine SAP

Active Comparator group

Description:

Turmeric extract standardized to 95% curcuminoids in combination with 5 mg of piperine per capsule will be administered orally (1 dose)

Treatment:

Dietary Supplement: Curcumin

Tumeric without piperine

Placebo Comparator group

Description:

Turmeric extract standardized to 95% curcuminoids without piperine will be administered orally (1 dose)

Treatment:

Dietary Supplement: Curcumin