Comparison of Curcumin Bioavailability

Pharmacokinetics After Oral Intake Clinical Trial

Official title:

Comparison of the Bioavailability of Different Curcumin Formulations in Healthy Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530436
• Other study ID #: HS-CUV-2018
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: November 7, 2018

Study information

• Verified date: January 2019
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 7, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy Volunteers with blood chemistry values within normal ranges

• Body mass index in a normal range

Exclusion Criteria:

• Pregnancy or lactation

• Alcohol and or drug abuse

• Use of dietary supplements or any medications except contraceptives

• Any known malignant, metabolic and endocrine diseases

• Previous cardiac infarction

• Dementia

• Blood pressure >140/90 mmHg

• Resting heart rate not within 50 to 90 beats per minute

• Participation in a clinical trial within the past 6 weeks

• Smoking

• Physical activity of more than 5 h per wk

Related Conditions & MeSH terms

• Pharmacokinetics After Oral Intake
• Safety After Oral Intake

Intervention

Dietary Supplement:
• Native turmeric extract
207 mg curcumin
• Native turmeric extract with 7-9% volatile turmeric oils
207 mg curcumin
• Turmeric extract plus mixture of phytochemicals
207 mg curcumin
• Cyclodextrin complex of curcuminoids
207 mg curcumin
• Turmeric oleoresin
207 mg curcumin
• Liposomal curcumin
207 mg curcumin
• Phytosomal curcumin
207 mg curcumin
• Micellar turmeric extract
207 mg curcumin

Locations

Country	Name	City	State
Germany	University of Hohenheim	Stuttgart	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h]	Total curcumin after deconjugation with ß-glucuronidase	0, 1, 2, 4, 6, 8 and 24 hours post dose
Primary	Mean area under the curve (AUC) of plasma concentration vs. time of total demethoxycurcumin [nmol/L*h]	Total demethoxycurcumin after deconjugation with ß-glucuronidase	0, 1, 2, 4, 6, 8 and 24 hours post dose
Primary	Mean area under the curve (AUC) of plasma concentration vs. time of total bisdemethoxycurcumin [nmol/L*h]	Total bisdemethoxycurcumin after deconjugation with ß-glucuronidase	0, 1, 2, 4, 6, 8 and 24 hours post dose
Primary	Maximum plasma concentration (Cmax) of total curcumin [nmol/L]	Total curcumin after deconjugation with ß-glucuronidase	0, 1, 2, 4, 6, 8 and 24 hours post dose
Primary	Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]	Total demethoxycurcumin after deconjugation with ß-glucuronidase	0, 1, 2, 4, 6, 8 and 24 hours post dose
Primary	Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]	Total bisdemethoxycurcumin after deconjugation with ß-glucuronidase	0, 1, 2, 4, 6, 8 and 24 hours post dose
Primary	Time to reach maximum plasma concentration (Tmax) of total curcumin [h]	Total curcumin after deconjugation with ß-glucuronidase	0, 1, 2, 4, 6, 8 and 24 hours post dose
Primary	Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]	Total demethoxycurcumin after deconjugation with ß-glucuronidase	0, 1, 2, 4, 6, 8 and 24 hours post dose
Primary	Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]	Total bisdemethoxycurcumin after deconjugation with ß-glucuronidase	0, 1, 2, 4, 6, 8 and 24 hours post dose

External Links

•   Website of the research group