- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01481389
The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects
September 17, 2012 updated by: Unilever R&D
The purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters.
Hypothesis: theobromine has a positive effect on blood lipid parameters.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gieres, France, 38610
- Eurofins Optimed
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician)
- Willing and able to participate in the study protocol
- Written informed consent
- Age 40-70 years
- 10-year risk of developing CHD <10%, based on data from the Framingham Heart Study
- BMI > 18 and < 30 kg/m2
- Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by research physician
- Willing to comply with the dietary restrictions of the study.
- Accessible veins on arm(s) as determined by examination at screening
Exclusion Criteria:
- Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
- Diabetes mellitus
- Reported alcohol consumption > 14 units/week (female) or > 21 units/week (male)
- Currently on a medically prescribed diet, or slimming diet
- Reported weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination
- Reported intense sporting activities > 10 h/w
- Use of prescribed medication which may interfere with study measurements, as judged by the physician
- Use of antibiotics in the three months before screening or during the study.
- Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months preceding the study and during the study itself
- Reported intolerance to test products or other food products provided during the study
- Blood donation 1 month (males) or 2 months (females) prior to screening and during the study
- Reported participation in another nutritional or biomedical trial 3 months before screening or during the study.
- Extreme coffee consumption
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo drink
|
200 ml drink (no added theobromine or cocoa)
|
Active Comparator: Theobromine drink
|
200 ml drink with added theobromine (no cocoa added)
|
Active Comparator: Cocoa drink
|
200 ml drink with cocoa (no theobromine added)
|
Active Comparator: Cocoa and theobromine drink
|
200 ml drink with added cocoa and theobromine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood lipids
Time Frame: after 4 weeks intervention
|
after 4 weeks intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: After 4 weeks intervention
|
After 4 weeks intervention
|
Heart rate
Time Frame: After 4 weeks intervention
|
After 4 weeks intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nicole Neufingerl, MSc, Unilever R&D
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
November 22, 2011
First Submitted That Met QC Criteria
November 28, 2011
First Posted (Estimate)
November 29, 2011
Study Record Updates
Last Update Posted (Estimate)
September 18, 2012
Last Update Submitted That Met QC Criteria
September 17, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10022V
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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