Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Curcuma longa L is widely cultivated in South-East Asian countries. It has a long history of use in food as a spice, mainly as an ingredient in many varieties of curry powders and sauces, where curcumin from turmeric is a main colouring substance. Curcumin is widely used to color many foods. Several forms of curcumin are available on the market but their absorption by the body has not been studied for all of the forms. Hence, we plan to study different curcumin supplements and their absorption in humans.

Who can participate?
Healthy people aged between the 18 and 55 can participate in the study.

What does the study involve?
Participants will be randomly assigned to have four types of curcumin supplements with a glass of water. Following consent, each participant will complete four visits. Participants will be given a different supplement at each visit. Each visit will be separated by at least 7 days and will follow identical study procedures, except for the consumption of a different curcumin supplement. Blood samples will be drawn at various intervals after taking in the supplements and will be tested for curcumin components. After the 4-hour and 8-hour blood samples have been drawn, a turmeric-free meal will be provided. Both the investigators and the participants will not know which supplement is consumed during each visit.

What are the possible benefits and risks of participating?
The results of this study will help people to choose the right supplement for better absorption. A possible risk is pain during the collection of the blood sample.

Where is the study run from?
Increnovo LLC, USA.

When is study starting and how long is it expected to run for?
The study ran from May to July 2013.

Who is funding the study?
OmniActives Health Technologies Ltd, India.

Who is the main contact?
Dr Vijaya Juturu

Trial website

Contact information



Primary contact

Dr Ralf Jaeger


Contact details

Increnovo LLC
2138 E Lafayette Place
United States of America

Additional identifiers

EudraCT number number

Protocol/serial number

Increnovo 13-07 [OAHTCUR2013]

Study information

Scientific title

Comparative absorption of different curcumin formulations


Study hypothesis

More and more preclinical studies support the idea that curcumin, a plant-derived natural polyphenol, could be a promising treatment for various chronic diseases. However, poor bio-availability has limited its efficacy in clinical trials. Very limited data is available on different curcumin formulations. The techniques and methods employed to produce these formulations may affect the bio-availability of the curcumin. We hypothesized that relative absorption of curcumin is very important to influence efficacy.

Ethics approval

Spartans, The University of Florida Tampa approved protocol on Feb7, 2013 [Ref: 13-07].

Study design

Randomized single-center single dose cross-over study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet




Frequency: Single dose, randomized, double blinded, cross-over study design; Dose: 376 mg for (BCM-95® [Dolcas], Meriva® [Indena], and Curcumax UltraSol Dry Nutrient System™ [DNS] [OmniActive]), and 1800 mg for C3 Complextrade mark, (Sabinsa Corporation).
Intervention: Subjects will be administered with curcumin supplements.
Four treatments [C3 Complextrade mark, (Sabinsa Corporation), BCM-95® (Dolcas), Meriva® (Indena), and Curcumax UltraSol Dry Nutrient System™ (DNS) (OmniActive)] will be administered with a glass of water. After a 7-day washout period, this process will be repeated for the two remaining study visits. Subjects will be administered a different treatment than the previous visit, until all four treatments will be administered.The blood plasma samples will be evaluated for curcuminoids [curcumin, demethoxycurcumin, and bisdemethoxycurcumin] and tetrahydrocurcumin . Prior to testing, each volunteer underwent screening and the consent visit to ensure eligibility and voluntary willingness to participate. Following consent, each volunteer completed 4 treatments each in a randomized, double-blinded order separated by at least 7 days. A baseline blood sample was collected and one of four treatment dosages of curcumin was consumed with water. Blood samples will be drawn at 1, 2, 3, 4, 5, 6, 8 and 12 hours intervals following product consumption. After the 4-hour and 8-hour blood samples have been drawn, a turmeric-free meal will be provided. Each subsequent trial will be separated by at least 7 days as a washout period and followed identical study procedures, except for the consumption of a different curcumin formulation. Product formulations will be blinded to both the investigators and the volunteers will be coded so that neither knew which formulation is consumed during each trial.

Intervention type



Not Applicable

Drug names


Primary outcome measure

1. Peak plasma concentrations (TMax),
2. Areas under the plasma concentration-time curves (AUC0-6h, AUC0-12h and AUC0-α), CMax and t1/2

Plasma levels of major curcuminoids [curcumin, demethoxycurcumin, bisdemethoxycurcumin and tetrahydrocurcumin] will be evaluated at 0, 1, 2, 3, 4, 5, 6, 8 and 12 hours. Peak plasma concentrations (TMax), areas under the plasma concentration-time curves (AUC0-6h, AUC0-12h and AUC0-α), CMax and t1/2 will be calculated.

Secondary outcome measures


Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Normal Healthy Individuals
2. Age: 18-55 y
3. Males and females
4. Must be able to perform required testing
5. Participants agreed to sign an informed consent form

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Pregnancy
2. Use of prescription medications
3. Gastrointestinal conditions
4. Diabetics
5. Alcohol and/or substance abuse history, and/or allergies to turmeric or curcumin
6. Subjects consuming any foods or supplements containing curcumin

Recruitment start date


Recruitment end date



Countries of recruitment

United States of America

Trial participating centre

Increnovo LLC
United States of America

Sponsor information


OmniActive Health Technologies (India and USA)

Sponsor details

c/o Vijaya Juturu
67 East Park Place
Suite 500
United States of America

Sponsor type




Funder type


Funder name

OmniActive Health Technologies

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2014 results in:

Publication citations

Additional files

Editorial Notes

31/07/2018: Internal review. 29/12/2015: Publication reference added.