Choline UptakeCUPNCT03822169
Choline Uptake Study
A study testing Choline added as a phospholipid and Choline added as a salt in people with Choline Uptake and Kinetics, run by Wageningen University and Research at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Choline Uptake, Kinetics
- What is being tested?
- Choline added as a phospholipid and Choline added as a salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Feb 2019to 19 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
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.
Read the 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.
- Conditions
- Choline Uptake, Kinetics
- Being tested
- Choline added as a phospholipid, Choline added as a salt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choline added as a phospholipidDietary supplement
A shake with 3000 mg choline added as a phospholipid
Choline added as a saltDietary supplement
A shake with 3000 mg choline added as a salt
| Study group | Role | What they receive |
|---|---|---|
| Choline added as a phospholipid | Experimental | A shake with phospholipid-bound choline (and bound DHA), Receives: Dietary Supplement: Choline added as a phospholipid |
| Choline added as a salt | Active comparator | control shake with choline added as a salt and added DHA. Receives: Dietary Supplement: Choline added as a salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in plasma choline concentration
postprandial test, determine choline in blood samples collected before and after a shake
Measured: 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
Measured: 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
Measured: blood samples will be taken before and up to 6 hours after shake consumption
Secondary outcomes (1)
Change in plasma DHA concentration
postprandial test, determine DHA in blood samples collected before and after a shake
Measured: blood samples will be taken before and up to 6 hours after shake consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start5 Feb 2019
- Primary completion19 Feb 2019
- Study completion19 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choline UptakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- AAK
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
- Investigators
- Diederik Esser, PhD, Principal investigator, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822169
- Sponsor's protocol ID
- NL67054.081.18
- Acronym
- CUP
- Status last verified
- Apr 2019
- First submitted
- 25 Jan 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choline Uptake Study
- ClinicalTrials.gov ID
- NCT03822169
- Acronym / sponsor ID
- CUP / NL67054.081.18
- Conditions
- Choline Uptake, Kinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- AAK
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Choline added as a phospholipid | Experimental | Dietary Supplement: Choline added as a phospholipidA shake with phospholipid-bound choline (and bound DHA), |
| Choline added as a salt | Active comparator | Dietary Supplement: Choline added as a saltcontrol shake with choline added as a salt and added DHA. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choline added as a phospholipidA shake with 3000 mg choline added as a phospholipid | Dietary supplement | Choline added as a phospholipid |
| Choline added as a saltA shake with 3000 mg choline added as a salt | Dietary supplement | Choline added as a salt |
Primary outcome
change in plasma choline concentration
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
change in plasma betaine concentration
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
change in plasma dimethylglycine concentration
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
1 secondary outcome
Change in plasma DHA concentration
Time frame: blood samples will be taken before and up to 6 hours after shake consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Choline Uptake
RecruitingPhase 3
Choline-PET: Exploratory Study Assessing the Potential Role of F-choline PET Imaging in New and Emerging Indications
Lesion With Known or Suspected F-choline Uptake
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diederik Esser, PhD principal investigator
Wageningen University and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choline added as a phospholipid and Choline added as a salt in people with Choline Uptake and Kinetics, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in plasma choline concentration (time frame: blood samples will be taken before and up to 6 hours after shake consumption). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.