Skip to main content
OpenTrials
Completed

NCT Number: NCT03530436

Comparison of Curcumin Bioavailability

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Safety After Oral Intake Pharmacokinetics After Oral Intake

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Native turmeric extract

Dietary Supplement

207 mg curcumin

Native turmeric extract with 7-9% volatile turmeric oils

Dietary Supplement

207 mg curcumin

Turmeric extract plus mixture of phytochemicals

Dietary Supplement

207 mg curcumin

Cyclodextrin complex of curcuminoids

Dietary Supplement

207 mg curcumin

Turmeric oleoresin

Dietary Supplement

207 mg curcumin

liposomal curcumin

Dietary Supplement

207 mg curcumin

Phytosomal curcumin

Dietary Supplement

207 mg curcumin

Micellar turmeric extract

Dietary Supplement

207 mg curcumin

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

Comparison of the Bioavailability of Different Curcumin Formulations in Healthy Humans

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.