NCT03822169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

February 5, 2019

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2019

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

14 days

First QC Date

January 25, 2019

Last Update Submit

April 11, 2019

Conditions

Choline UptakeKinetics

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Change in plasma DHA concentration

    blood samples will be taken before and up to 6 hours after shake consumption

Study Arms (2)

Choline added as a phospholipid

EXPERIMENTAL

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

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.

Dietary Supplement: Choline added as a salt

Interventions

Choline added as a phospholipidDIETARY_SUPPLEMENT

A shake with 3000 mg choline added as a phospholipid

Choline added as a phospholipid
Choline added as a saltDIETARY_SUPPLEMENT

A shake with 3000 mg choline added as a salt

Choline added as a salt

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

Study Officials

  • Diederik Esser, PhD

    Wageningen University and Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
project leader clinical trials

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 30, 2019

Study Start

February 5, 2019

Primary Completion

February 19, 2019

Study Completion

February 19, 2019

Last Updated

April 12, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)