Choline Uptake Study (CUP)

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.

Study Overview

• Status: Completed
• Conditions: Choline Uptake; Kinetics
• Intervention / Treatment: Dietary supplement: Choline added as a phospholipid; Dietary supplement: Choline added as a salt

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Stichting Wageningen Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Choline added as a phospholipid; A shake with phospholipid-bound choline (and bound DHA),	Dietary supplement: Choline added as a phospholipid; A shake with 3000 mg choline added as a phospholipid
Active Comparator: Choline added as a salt; control shake with choline added as a salt and added DHA.	Dietary supplement: Choline added as a salt; A shake with 3000 mg choline added as a salt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: AAK

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Actual): February 19, 2019
• Study Completion (Actual): February 19, 2019

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: NL67054.081.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No