The Acute Effect of 2 Different Serving Regimens of Theobromine on Physiological Effects

Study Overview
=================
Brief Summary
-----------------
The main aim of this study is to determine whether there is a difference in the physiological effects of theobromine when provided via a single serving compared to multiple servings adding up to the same amount of theobromine provided on a day. This study also aims to study the pharmacokinetics of theobromine after administration once per day versus administration 4 times per day. Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is given in 4 smaller doses.

Official Title
-----------------
The Acute Effect of 2 Different Serving Regimens of Theobromine on Theobromine Concentration in the Blood & Physiological Effects

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

Intervention / Treatment
-----------------
* Dietary Supplement: Theobromine
* Dietary Supplement: 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) Age 40-70 years BMI ≥ 18 and ≤ 30 kg/m2 Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged non clinically significant by research physician Written informed consent Exclusion Criteria: Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure) Diabetes mellitus Reported weight loss or gain of 10% body weight or more during a period of 6 months prior to screening Reported intense sporting activities > 10 h/week Use of over-the -counter 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 run-in period. 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 High caffeine consumption: reported consumption of more than 8 cups/cans of caffeine-containing drinks per day, i.e. coffee, black or green tea and cola (also cola light, diet & zero) OR consumption of more than 1 energy drink per day

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: Single serving of theobromine<br> | Dietary Supplement: Theobromine<br>* Single dose of theobromine<br>|
| Active Comparator: Multiple servings of theobromine<br> | Dietary Supplement: Theobromine<br>* Multiple doses of theobromine<br>|
| Placebo Comparator: Placebo capsules<br> | Dietary Supplement: Placebo<br>* Placebo capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods | 
| Hematocrit |  | Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods | 
| Serum blood lipids |  | Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods | 
| Serum glucose and insulin concentrations |  | Measured on day 1 and 2 (at time points -5min, 3h, 5h, 10h and 24h) for 3 periods | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
theobromine, heart rate, blood lipids