Comparison of Curcumin Bioavailability

Comparison of the Bioavailability of Different Curcumin Formulations in Healthy Humans

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Stuttgart, Baden-Württemberg, Germany, 70599
      • University of Hohenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Native turmeric extract; 6 capsules of native curcumin (207 mg curcumin)	Dietary supplement: Native turmeric extract; 207 mg curcumin
Experimental: Native turmeric extract with 7-9% volatile turmeric oils; 6 capsules of the formulation; dosage normalized to 207 mg curcumin	Dietary supplement: Native turmeric extract with 7-9% volatile turmeric oils; 207 mg curcumin
Experimental: Turmeric extract plus mixture of phytochemicals; 6 capsules of the formulation; dosage normalized to 207 mg curcumin	Dietary supplement: Turmeric extract plus mixture of phytochemicals; 207 mg curcumin
Experimental: Cyclodextrin complex of curcuminoids; 6 capsules of the formulation; dosage normalized to 207 mg curcumin	Dietary supplement: Cyclodextrin complex of curcuminoids; 207 mg curcumin
Experimental: Turmeric oleoresin; 6 capsules of the formulation; dosage normalized to 207 mg curcumin	Dietary supplement: Turmeric oleoresin; 207 mg curcumin
Experimental: Liposomal curcumin; 6 capsules of the formulation; dosage normalized to 207 mg curcumin	Dietary supplement: Liposomal curcumin; 207 mg curcumin
Experimental: Phytosomal curcumin; 6 capsules of the formulation; dosage normalized to 207 mg curcumin	Dietary supplement: Phytosomal curcumin; 207 mg curcumin
Experimental: Micellar turmeric extract; 6 capsules of the formulation; dosage normalized to 207 mg curcumin	Dietary supplement: Micellar turmeric extract; 207 mg curcumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h]	Total curcumin after deconjugation with β-glucuronidase	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	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	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	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	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	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	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	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	0, 1, 2, 4, 6, 8 and 24 hours post dose

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Investigators: Principal Investigator: Jan Frank, Prof. Dr., University of Hohenheim

Publications and helpful links

Helpful Links

• Website of the research group

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): August 10, 2018
• Study Completion (Actual): November 7, 2018

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Bioavailability; Curcumin; Demethoxycurcumin; Bisdemethoxycurcumin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Protective Agents; Antioxidants; Turmeric extract; Curcumin
• Other Study ID Numbers: HS-CUV-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No