An interventional study of Native turmeric extract and Native turmeric extract with 7-9% volatile turmeric oils in Safety After Oral Intake and Pharmacokinetics After Oral Intake, sponsored by University of Hohenheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-10.
Sponsored by University of Hohenheim · Not applicable, Interventional, and Basic science
The curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based on its natural low bioavailability and the number of its effects on human health, several approaches such as increasing its water solubility or inhibiting its metabolism were taken to improve its bioavailability. Pharmacokinetics of curcumin from various supplements using those different mechanisms have been compared to the one of native curcumin. The investigator's study here will compare the bioavailability of curcumin from eight different curcumin formulations with native curcumin and between themselves. The study will folllow a single dose (in form of curcumin formulations, normalized to 207 mg curcumin), placebo-controlled, randomized, double-blind, nine-armed crossover study design with ≥ 1-week washout periods. Plasma samples will be collected at intervals up to 24 hours after intake. Investigators will compare the pharmacokinetics between the different curcumin formulations and to native curcumin.
University of Hohenheim is the lead sponsor of 42 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 capsules of native curcumin (207 mg curcumin)
Dietary Supplement: Native turmeric extract
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Native turmeric extract with 7-9% volatile turmeric oils
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Turmeric extract plus mixture of phytochemicals
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Cyclodextrin complex of curcuminoids
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Turmeric oleoresin
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Liposomal curcumin
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Phytosomal curcumin
6 capsules of the formulation; dosage normalized to 207 mg curcumin
Dietary Supplement: Micellar turmeric extract
207 mg curcumin
207 mg curcumin
207 mg curcumin
207 mg curcumin
207 mg curcumin
207 mg curcumin
207 mg curcumin
207 mg curcumin
Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h]
Total curcumin after deconjugation with β-glucuronidase
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total demethoxycurcumin [nmol/L*h]
Total demethoxycurcumin after deconjugation with β-glucuronidase
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total bisdemethoxycurcumin [nmol/L*h]
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
Total curcumin after deconjugation with β-glucuronidase
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
Total demethoxycurcumin after deconjugation with β-glucuronidase
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Time to reach maximum plasma concentration (Tmax) of total curcumin [h]
Total curcumin after deconjugation with β-glucuronidase
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]
Total demethoxycurcumin after deconjugation with β-glucuronidase
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Plan to share: No
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University of Hohenheim