Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG, Netherlands
NCT Number: NCT03822169
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.
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Notify Me30 year–70 year
All sexes
Interventional
Not applicable
Wageningen, Gelderland, 6708 WG, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A shake with 3000 mg choline added as a phospholipid
A shake with 3000 mg choline added as a salt
Time frame: blood samples will be taken before and up to 6 hours after shake consumption
postprandial test, determine choline in blood samples collected before and after a shake
Time frame: blood samples will be taken before and up to 6 hours after shake consumption
postprandial test, determine betaine in blood samples collected before and after a shake
Time frame: blood samples will be taken before and up to 6 hours after shake consumption
postprandial test, determine dimethylglycine in blood samples collected before and after a shake
Time frame: blood samples will be taken before and up to 6 hours after shake consumption
postprandial test, determine DHA in blood samples collected before and after a shake
Wageningen University and Research
Other
Acronym: CUP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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