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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: Single serving of theobromine | Active Comparator |
| |
| Multiple servings of theobromine | Active Comparator |
| |
| Placebo capsules | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theobromine | Dietary Supplement | Single dose of theobromine |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wieneke Koppenol, MSc | Unilever R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Optimed | Gières | France |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013805 | Theobromine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Theobromine | Dietary Supplement | Multiple doses of theobromine |
|
| Placebo | Dietary Supplement | Placebo capsules |
|
| 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 |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |