Choline Uptake Study

NCT ID: NCT03822169

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-05
• Study Completion Date: 2019-02-19

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.

Conditions

Choline Uptake; Kinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Choline added as a phospholipid

A shake with phospholipid-bound choline (and bound DHA),

Group Type: EXPERIMENTAL

Choline added as a phospholipid

Intervention Type: DIETARY_SUPPLEMENT

A shake with 3000 mg choline added as a phospholipid

Choline added as a salt

control shake with choline added as a salt and added DHA.

Group Type: ACTIVE_COMPARATOR

Choline added as a salt

Intervention Type: DIETARY_SUPPLEMENT

A shake with 3000 mg choline added as a salt

Interventions

Choline added as a phospholipid

A shake with 3000 mg choline added as a phospholipid

Intervention Type: DIETARY_SUPPLEMENT

Choline added as a salt

A shake with 3000 mg choline added as a salt

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AAK

OTHER

Sponsor Role: collaborator

Wageningen University and Research

OTHER

Sponsor Role: lead

Responsible Party

Diederik Esser

project leader clinical trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diederik Esser, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University and Research

Locations

Stichting Wageningen Research

Wageningen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL67054.081.18

Identifier Type: -

Identifier Source: org_study_id