Comparison of Curcumin Bioavailability

• ClinicalTrials.gov Identifier: NCT03530436
• Recruitment Status: Completed
• First Posted: May 21, 2018
• Last Update Posted: January 10, 2019
• Sponsor: University of Hohenheim
• Information provided by (Responsible Party): University of Hohenheim

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Safety After Oral Intake; Pharmacokinetics After Oral Intake	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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Comparison of the Bioavailability of Different Curcumin Formulations in Healthy Humans
• Actual Study Start Date: June 7, 2018
• Actual Primary Completion Date: August 10, 2018
• Actual Study Completion Date: November 7, 2018

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Germany

University of Hohenheim

Stuttgart, Baden-Württemberg, Germany, 70599

Sponsors and Collaborators

University of Hohenheim

Investigators

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

More Information

Additional Information:

Website of the research group 

• Responsible Party: University of Hohenheim
• ClinicalTrials.gov Identifier: NCT03530436 History of Changes
• Other Study ID Numbers: HS-CUV-2018
• First Posted: May 21, 2018
• Last Update Posted: January 10, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Hohenheim:

Bioavailability; Pharmacokinetics; Curcumin; Demethoxycurcumin; Bisdemethoxycurcumin

Additional relevant MeSH terms:

Curcumin; Turmeric extract; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antioxidants; Protective Agents