Plain English Summary
Background and study aims
The spice turmeric has been used for centuries throughout Asia for medicinal purposes, especially in the traditional Ayurvedic approach to nutrition. Curcumin is a substance found in turmeric. However, curcumin is not absorbed by the body very effectively. Different formulations of curcumin are already on the market, but haven’t been examined under the same study conditions. The aim of this study is to analyze four different formulations of curcumin in one clinical setting.
Who can participate?
Healthy people aged between 18 and 35.
What does the study involve?
Participants are supplemented with visually identical gel capsules of each of the four supplements. Blood samples are taken before taking the supplements and hourly for 12 hours afterwards and analyzed to determine the levels of curcumin in the blood.
What are the possible benefits and risks of participating?
The results of this study will help people to choose the right supplement for better oral absorption. A possible risk is pain during the collection of the blood sample.
Where is the study run from?
Increnovo LLC (USA).
When is the study starting and how long is it expected to run for?
May to July 2013.
Who is funding the study?
Wacker Chemie AG (Germany).
Who is the main contact?
Dr Helmut Reuscher
helmut.reuscher@wacker.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WAC_CUR01_2013
Study information
Scientific title
Analysis of different formulations of curcumin for improved relative oral bioavailability
Acronym
Study hypothesis
Turmeric has been widely used for centuries and is a well-known substance used in the traditional Ayurvedic approach to nutrition. Modern science has provided a solid basis for such uses and current clinical trials make curcumin, the main polyphenol derived from turmeric, one of the best investigated natural compounds to date. Strong molecular evidence has been published for its potency to target e.g. multiple inflammatory diseases. However, curcumin cannot achieve its optimum therapeutic outcomes due to its low solubility and poor bioavailability. Curcumin has shown significant efficacy in cell culture studies but has shown limited efficacy in clinical studies when administered in conventional oral formulations. We hypothesized that relative absorption of oral curcumin formulations is very important to influence efficacy. There is little and very diverse data available on bioavailable curcumin formulations.
Ethics approval
The University of Florida Tampa IRB, 07/02/2013, Ref: 13-07
Study design
Randomized single-center single-dose cross-over study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nutritional supplement
Intervention
Four curcumin supplement formulations were used (BCM-95® [Dolcas], Meriva® [Indena], C3 ComplexTM [Sabinsa Corporation] and CAVAMAX® W8 Curcumin/CAVACURMIN® [Wacker Chemie AG].
All volunteers were supplemented with visually identical 6 hard gel capsules of each of the four study materials per setting, resulting in 376 mg of total curcuminoids for CAVAMAX® W8 Curcumin/CAVACURMIN®, BCM-95® and Meriva® and 1,800 mg of total curcuminoids for StdC (C3 ComplexTM) in accordance with the study dosage established by Cuomo et al.
Each dose was separated by a washout period of at least 7 days and blood plasma curcumin levels were assessed continuously for 12 hours following each treatment.
First the baseline blood sample was obtained, followed by one of four treatment dosages of curcumin which were consumed with water. Further blood samples were then drawn at the time points of 1, 2, 3, 4, 5, 6, 8 and 12 hours following product supplementation. Each time after the 4-hour and 8-hour blood sample draw, a low-fat and turmeric-free standardized meal was delivered. All subjects completed 4 trials with 9 blood draws each in a randomized, double-blinded order. Blood plasma samples were analyzed by tandem mass spectrometry detection to determine curcumin, demethoxycurcumin, and bisdemethoxycurcumin and tetrahydrocurcumin levels.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
1. Peak plasma concentrations Tmax (h)
2. Area under the plasma concentration time-curve (AUC 0-12), Cmax (ng/mL) and T1/2 (h)
Plasma levels of 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 (AUC0-12h), Cmax, t1/2 and relative absorption will be calculated.
Secondary outcome measures
None
Overall trial start date
02/05/2013
Overall trial end date
06/07/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy individuals
2. Age: 20-35 years
3. Males and females
4. Participants agreed to sign an informed consent form
5. Participants must be able to perform required testing
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
12
Participant exclusion criteria
1. Consuming any curcumin-containing supplements or foods for two weeks prior to testing
2. History of any of the following: hyperacidity, gastric/duodenal ulcers, gastrointestinal problems, gallbladder issues
3. Use of any blood thinners/anti-thrombotic agents or NSAIDS
4. Prior use of blood sugar-lowering agents, H2 blockers, or proton pump inhibitors
5. Known allergies to soy
6. Diabetics
7. Pregnancy
Recruitment start date
02/05/2013
Recruitment end date
06/07/2013
Locations
Countries of recruitment
United States of America
Trial participating centre
Increnovo LLC
53202
United States of America
Sponsor information
Organisation
Wacker Chemie AG (Germany)
Sponsor details
Hanns-Seidel-Platz 4
Muenchen
81737
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Wacker Chemie AG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary