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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01481389 |
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Date of registration:
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22/11/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects
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Scientific title:
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The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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152 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01481389 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Wieneke Koppenol, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Unilever R&D |
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Name:
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Nicole Neufingerl, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Unilever R&D |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiovascular Diseases
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Intervention(s)
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Dietary Supplement: Theobromine
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Dietary Supplement: Cocoa
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Dietary Supplement: Cocoa and theobromine
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Dietary Supplement: Placebo
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Primary Outcome(s)
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Blood lipids
[Time Frame: after 4 weeks intervention]
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Secondary Outcome(s)
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Heart rate
[Time Frame: After 4 weeks intervention]
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Blood pressure
[Time Frame: After 4 weeks intervention]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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