Clinical trial NCT03822169: Choline Uptake Study
Official title: Choline Uptake Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Choline Uptake
Kinetics
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
Collaborators: name: AAK
First posted: 2019-01-30
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy men and women
* Age between 30 and 70 years
* Body mass index (BMI) between 18.5 and 24.9 kg/m2
* Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor)

Exclusion Criteria:

* Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
* History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
* History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
* Kidney dysfunction (self-reported)
* Use of medication that may influence the study results,
* such as laxatives, stomach protectors and drugs that can affect intestinal motility.
* Use of choline or fish oil supplements
* Reported slimming, medically prescribed or vegan diet
* Current smokers
* Alcohol intake ≥4 glasses of alcoholic beverages per day
* Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
* Abuse of illicit drugs
* Food allergies for products that we use in the study
* Participation in another clinical trial at the same time
* Being an employee of the department Consumer Science \& Health group of Wageningen Food \& Biobased Research and/or Human Nutrition and Health

Primary outcomes:
measure: change in plasma choline concentration
timeFrame: blood samples will be taken before and up to 6 hours after shake consumption
measure: change in plasma betaine concentration
timeFrame: blood samples will be taken before and up to 6 hours after shake consumption
measure: change in plasma dimethylglycine concentration
timeFrame: blood samples will be taken before and up to 6 hours after shake consumption
Secondary outcomes:
measure: Change in plasma DHA concentration
timeFrame: blood samples will be taken before and up to 6 hours after shake consumption
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Stichting Wageningen Research
state: Gelderland
Study officials:
affiliation: Wageningen University and Research
name: Diederik Esser, PhD
role: PRINCIPAL_INVESTIGATOR
References: