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| Name | Class |
|---|---|
| AAK | OTHER |
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The study is a randomised, cross-over, double blind, controlled trial in which study participants will visit the research facility on two occasions under fasting conditions with a washout period of one week. During each visit, study subjects will receive a test shake with phospholipid-bound choline or a control shake with choline added as a salt and DHA added separately. The two shakes will be given in randomised order and blood will be collected via a catheter before and up-to 6 hours after choline consumption. All study participants will receive a standardised evening meal prior to each study day and asked not to drink alcohol or perform heavy exercise the day before each study day. Study subjects are also asked to avoid choline rich products the day before each test day. Study participants are offered a meal after the test day.
Choline is water-soluble vitamin-like essential nutrient. It is made in small amounts by the liver, but humans need to receive choline through the diet or by supplementation for proper health. Pregnancy and lactation are times when demand for choline is especially high. Infant formula not made from cow's milk is therefore supplemented with choline. Choline is therefore widely used. It is normally added to food products as a salt. However, if choline is present in a natural form, bound to phospholipids, it may be more efficiently absorbed. Docosahexaenoic acids (DHA) are also bound to these phospholipids.
The primary objective is determine choline uptake and bioavailability after consumption of a test shake with phospholipid-bound choline (and DHA), and to compare this to a control shake with choline added as a salt (and DHA added as an oil). Secondary objective is to compare the uptake and bioavailability of DHA after the two shakes.
The study is a cross-over, double blind, controlled trial in which study participants will visit the research facility on two occasions under fasting conditions. Subjects will receive two different choline products in randomized order with a washout period of one week. Blood will be collected via a catheter before and up-to 6 hours after choline consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choline added as a phospholipid | Experimental | A shake with phospholipid-bound choline (and bound DHA), |
|
| Choline added as a salt | Active Comparator | control shake with choline added as a salt and added DHA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline added as a phospholipid | Dietary Supplement | A shake with 3000 mg choline added as a phospholipid |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in plasma choline concentration | postprandial test, determine choline in blood samples collected before and after a shake | blood samples will be taken before and up to 6 hours after shake consumption |
| change in plasma betaine concentration | postprandial test, determine betaine in blood samples collected before and after a shake | blood samples will be taken before and up to 6 hours after shake consumption |
| change in plasma dimethylglycine concentration | postprandial test, determine dimethylglycine in blood samples collected before and after a shake | blood samples will be taken before and up to 6 hours after shake consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma DHA concentration | postprandial test, determine DHA in blood samples collected before and after a shake | blood samples will be taken before and up to 6 hours after shake consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diederik Esser, PhD | Wageningen University and Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stichting Wageningen Research | Wageningen | Gelderland | 6708 WG | Netherlands |
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| Choline added as a salt | Dietary Supplement | A shake with 3000 mg choline added as a salt |
|