Comparison of Curcumin Bioavailability

Not Applicable

Completed

• Conditions: Pharmacokinetics After Oral Intake; Safety After Oral Intake
• Interventions: Dietary Supplement: Turmeric oleoresin; Dietary Supplement: Liposomal curcumin; Dietary Supplement: Micellar turmeric extract; Dietary Supplement: Turmeric extract plus mixture of phytochemicals; Dietary Supplement: Native turmeric extract with 7-9% volatile turmeric oils; Dietary Supplement: Native turmeric extract; Dietary Supplement: Cyclodextrin complex of curcuminoids; Dietary Supplement: Phytosomal curcumin

• Registration Number: NCT03530436
• Lead Sponsor: University of Hohenheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-21
• Study Start: 2018-06-07
• Primary Completion: 2018-08-10
• Study Completion: 2018-11-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Turmeric oleoresin	Turmeric oleoresin	6 capsules of the formulation; dosage normalized to 207 mg curcumin
Liposomal curcumin	Liposomal curcumin	6 capsules of the formulation; dosage normalized to 207 mg curcumin
Micellar turmeric extract	Micellar turmeric extract	6 capsules of the formulation; dosage normalized to 207 mg curcumin
Turmeric extract plus mixture of phytochemicals	Turmeric extract plus mixture of phytochemicals	6 capsules of the formulation; dosage normalized to 207 mg curcumin
Native turmeric extract with 7-9% volatile turmeric oils	Native turmeric extract with 7-9% volatile turmeric oils	6 capsules of the formulation; dosage normalized to 207 mg curcumin
Native turmeric extract	Native turmeric extract	6 capsules of native curcumin (207 mg curcumin)
Cyclodextrin complex of curcuminoids	Cyclodextrin complex of curcuminoids	6 capsules of the formulation; dosage normalized to 207 mg curcumin
Phytosomal curcumin	Phytosomal curcumin	6 capsules of the formulation; dosage normalized to 207 mg curcumin

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Hohenheim; 🇩🇪 Stuttgart, Baden-Württemberg, Germany