The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Theobromine
* Dietary Supplement: Cocoa
* Dietary Supplement: Cocoa and theobromine
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Theobromine drink<br> | Dietary Supplement: Theobromine<br>* 200 ml drink with added theobromine (no cocoa added)<br>|
| Active Comparator: Cocoa drink<br> | Dietary Supplement: Cocoa<br>* 200 ml drink with cocoa (no theobromine added)<br>|
| Placebo Comparator: Placebo drink<br> | Dietary Supplement: Placebo<br>* 200 ml drink (no added theobromine or cocoa)<br>|
| Active Comparator: Cocoa and theobromine drink<br> | Dietary Supplement: Cocoa and theobromine<br>* 200 ml drink with added cocoa and theobromine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipids |  | after 4 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | After 4 weeks intervention | 
| Heart rate |  | After 4 weeks intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood lipids, risk factor for cardiovascular diseases