Condition category
Not Applicable
Date applied
16/03/2017
Date assigned
21/03/2017
Last edited
21/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Curcumin, a bright yellow spice, is widely grown 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. Curcumin is widely used to colour 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. The aim of this study is to measure the absorption of two different curcumin supplements in healthy volunteers.

Who can participate?
Healthy volunteers aged between 18 and 55

What does the study involve?
Participants are randomly allocated to take either a standard curcumin supplement or a new supplement with a glass of water. On the morning of the study, participants arrive having fasted for at least 10 hours. Blood samples are taken before they take the supplement and after 15 minutes, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours. Participants record their diet for 3 days before and on the day of the study. A meal not containing curcumin is provided for lunch and dinner on the day of the study. Participants return 7 days later and the process is repeated with the other supplement. Blood samples are tested for levels of curcumin substances and are also stored for potential future testing.

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?
1. Texas Christian University (USA)
2. University of North Texas Health Science Center at Fort Worth (USA)

When is the study starting and how long is it expected to run for?
June 2016 to August 2017

Who is funding the study?
OmniActive Health Technologies Ltd (India)

Who is the main contact?
Dr Vijaya Juturu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vijaya Juturu

ORCID ID

http://orcid.org/0000-0002-7397-715X

Contact details

67 East Park Place
Suite 500
Morristown
07960
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CUR004-16

Study information

Scientific title

A randomized, double-blind, parallel study to compare the relative absorption of UltraSOL Curcumin and Curcumin reference product

Acronym

Study hypothesis

Despite its demonstrated effects, the benefit of curcumin is limited by its poor solubility, low absorption from the gut, rapid metabolism and rapid systemic elimination. While the major portion of ingested curcumin is excreted through the feces unmetabolized, the small portion that is absorbed is extensively converted to its water-soluble metabolites, glucuronides and sulfate, and excreted. The purpose of this study was to assess the bioavailability of two different oral curcumin formulations: a curcumin reference (standard) and a new, natural curcumin formulation (UltraSOL Curcumin (OmniActive) over the course of 24 hours (0, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours).

Ethics approval

Texas Christian University institutional review board, 07/08/2016, ref: 1605-071-1607

Study design

Single-dose randomized double-blind crossover design



Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Bioavailability of two different oral curcumin formulations

Intervention

Subjects will be randomised to receive one of two curcumin supplements: Curcumin standard formulation (1800 mg) or UltraSOL Curcumin (376 mg), administered with a glass of water. After a 7-day washout period, this process will be repeated with the other supplement for the two remaining study visits.

On the morning of supplementation, subjects will arrive having fasted for at least 10 hours. A baseline blood sample will be drawn prior to ingestion of supplement (0 hours). Thereafter, blood will be sampled at 15 minutes, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-ingestion. Subjects will record dietary intake for 3 days prior to and on the day of experimental protocol. A non-turmeric containing meal will be provided for lunch and dinner on the day of experimentation. Subjects will return 7 days after first experimental protocol to participate under alternative treatment. Blood from timepoints (0, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours) will subsequently be measured for curcuminoids (curcumin, demethoxycurcumin, bisdemethoxycurcumin, tetrahydrocurcumin) by HPLC. Blood from timepoints 15 minutes and 30 minutes, as well as additional samples from all other time points will be stored for potential future analysis of free curcuminoids (without the addition of glucuronidase). Descriptive statistics (mean, standard deviation) will be calculated. Area under the curve will be calculated in accordance with the trapezoidal method from 0 to 12 h and 0 to 24 h. Concentration max (Cmax) will be identified as the maximum concentration achieved over the 24 h period with corresponding time (tmax).

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

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 and 24 h. Peak plasma concentrations (TMax), areas under the plasma concentration-time curves (AUC0-6h, AUC0-12h and AUC0-24h), CMax and t max will be calculated. Relative absorption at 24h time point is helpful to observe normalization and safety of the product

Secondary outcome measures

None

Overall trial start date

30/06/2016

Overall trial end date

30/08/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

15

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

25/08/2016

Recruitment end date

30/10/2016

Locations

Countries of recruitment

United States of America

Trial participating centre

Texas Christian University
Harris College of Nursing & Health Sciences Department of Kinesiology TCU Box 297730
Fort Worth
76129
United States of America

Trial participating centre

University of North Texas Health Science Center at Fort Worth
Fort Worth
-
United States of America

Sponsor information

Organisation

OmniActive Health Technologies Ltd

Sponsor details

Cybertech House
First Floor
J.B. Sawant Road
Wagle Industrial Estate
Thane
400 604
India

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

OmniActive Health Technologies Ltd (India)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jonathan Oliver or Dr Vijaya Juturu

Intention to publish date

31/12/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes