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Completed

NCT Number: NCT03822169

Choline Uptake 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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Choline added as a phospholipid

Dietary Supplement

A shake with 3000 mg choline added as a phospholipid

Choline added as a salt

Dietary Supplement

A shake with 3000 mg choline added as a salt

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Change in plasma DHA concentration

    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

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Collaborators

  • AAK

Registry information

Acronym: CUP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2019
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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