Condition category
Circulatory System
Date applied
14/12/2015
Date assigned
22/12/2015
Last edited
16/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cardiovascular disease (CVD) is a general term used to describe disease of the heart or blood vessels. One of the best ways to predict whether someone is likely to develop CVD is by looking at the state of the endothelium (inner lining of blood vessels). In people who are at risk of developing CVD, the endothelium of their blood vessels is not able to expand (vasodilation) and contract (vasoconstriction) as well as it should do. For thousands of years, curcuminoids have been used in Eastern medicine to treat a range of health problems. Curcuminoids are natural chemicals found in the spice turmeric, which have been shown to have many properties which benefit health. The aim of this study is to find out whether curcuminoid supplements has an effect on endothelial function in mediated vasodilation (a technique to test how well arteries are able to expand after compression).

Who can participate?
Healthy adults between the ages of 19 and 29.

What does the study involve?
Participants are randomly allocated to one of three groups. Participants in the first group take capsules containing 50mg of curcuminoids every day for 8 weeks. Participants in the second group take capsules containing 200mg of curcuminoids every day for 8 weeks. Participants in the third group take capsules containing a placebo (dummy) every day for 8 weeks. At the start of the study and after 8 weeks, all participants undergo a flow-mediated dilation (FMD) test. This is done by inflating a blood pressure cuff around their arm to stop blood flow in the arm for 5 minutes. When the cuff is released, the diameter (width) of the artery is monitored for 3 minutes in order to see how long it takes to dilate back to its normal diameter.

What are the possible benefits and risks of participating?
Participants are given access to the results of their ultrasound scans and so can seek treatment if a problem with their circulation is discovered. There are no notable risks of taking part in the study, although participants may experience some discomfort when the blood pressure cuff is inflated around their arm.

Where is the study run from?
Texas Christian University (USA)

When is the study starting and how long is it expected to run for?
November 2014 to May 2015

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

Who is the main contact?
Dr Vajaya Juturu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vijaya Juturu

ORCID ID

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

Contact details

OmniActive Health Technologies Inc.
67 East Park Place
Suite 500
Morristown
Morristown
07960
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OAHTCUR002-2014

Study information

Scientific title

Effects of curcuminoids on endothelial function in young, healthy individuals

Acronym

Study hypothesis

The aim of this study is to investigate the effect of 50 mg curcuminoids and 200 mg curcuminoids on flow mediated vasodilation a predictive marker for endothelial function and important assessment for cardiovascular risk.

Ethics approval

Texas Christian University Institutional Review Board, 30/08/2014, ref: 1410-105-1410

Study design

Double-blind randomized placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Assessment of cardiovascular risk

Intervention

Participants are randomly allocated to one of three groups:
Group 1: Participants ingest 50 mg of curcuminoids every day for 8 weeks
Group 2: Participants ingest 200 mg of curcuminoids every day for 8 weeks
Group 3: Participants ingest a placebo every day for 8 weeks

At baseline and 8 weeks, participants in all groups undergo a flow-mediated dilation (FMD) test. The FMD procedure will be performed using an Acuson Aspen Ultrasound System in order to determine the diameter of the brachial artery. All FMD measures will be taken in a quiet, temperature controlled room after a period of rest (20 minutes). An initial ultrasound image of the brachial artery diameter will be obtained and used as a baseline measurement. A blood pressure cuff will then be placed on the participant’s forearm and inflated to 50 mmHg above their resting systolic blood pressure, as determined during measurement of vital signs, to occlude blood flow to the hand and forearm for a 5-minute period. After the cuff is released, the artery diameter will be monitored for 3 minutes using the ultrasound unit. The video clips will be analyzed using Medical Imaging Software which provides an average diameter for each clip. The final data will be expressed as the peak diameter compared to the pre-occlusion baseline diameter, reported in both absolute units (mm) and as a percent change.

Baseline artery diameter and maximal brachial artery diameter post-occlusion will be used to calculate FMD pre- and post-supplementation. In addition, a subset of analysis will be performed on subjects with ≤7% FMD to see the effect of two treatments compared to placebo.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Flow mediated dilation is measured using ultrasound scanning at baseline and 8 weeks in all participants
2. Flow mediated dilation is measured using ultrasound scanning at baseline and 8 weeks in a subset of participants who had an FMD of 7% or lower

Secondary outcome measures

None

Overall trial start date

02/11/2014

Overall trial end date

30/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 19 and 29 years inclusive
2. Meet the minimum recommendations for health and fitness by the American College of Sports Medicine
3. Non-smoking
4. Free from any musculoskeletal, medical or metabolic contraindications to exercise
5. Have not consumed any nutritional supplements and/or ergogenic aids for the preceding 9-week period and/or not have taken any anti-inflammatory medications for the previous month
6. Good general health as determined by a health history questionnaire
7. Female participamt must be currently taking oral contraceptive or post-menopausal (i.e. not pregnant)
8. Able to provide written and dated informed consent
9. Willing and able to comply with the protocol

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

N=60 (20 per treatment arm)

Participant exclusion criteria

1. Oarticipation in another clinical trial or consumption of investigational product within the previous thirty days
2. History of alcohol and/or drug abuse in the past 6 months or intends to consume either over the course of the study
3. Reported history of chronic or presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (systolic BP> 140 and/or diastolic BP> 90), thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease
4. Currently suffers from sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study
5. Subject has a known allergy or sensitivity to any ingredient in the test product
6. Any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk
7. History of difficulty swallowing large pills or tablets
8. Creatine use within 9 weeks prior to screening
9. History of orthopedic injury or surgery within the last 6 months
10. Has a contraindication to exercise utilized in research design
11. Subject has self-reported an abnormal resting ECG
12. Investigator is uncertain about subject’s capability or willingness to comply with the protocol requirements

Recruitment start date

10/11/2014

Recruitment end date

30/11/2014

Locations

Countries of recruitment

United States of America

Trial participating centre

Texas Christian University
2800 South University Drive
Fort Worth
76129
United States of America

Sponsor information

Organisation

OmniActive Health Technologies Inc.

Sponsor details

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

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 presentation of results data at relevant conferences and publication of results in a peer reviewed journal.

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27630772

Publication citations

Additional files

Editorial Notes

16/09/2016: Publication reference added.