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Trial record 10 of 180 for:    Phospholipids

Choline Uptake Study (CUP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03822169
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
AAK
Information provided by (Responsible Party):
Diederik Esser, Wageningen University and Research

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.

Condition or disease Intervention/treatment Phase
Choline Uptake Kinetics Dietary Supplement: Choline added as a phospholipid Dietary Supplement: Choline added as a salt Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Choline Uptake Study
Actual Study Start Date : February 5, 2019
Actual Primary Completion Date : February 19, 2019
Actual Study Completion Date : February 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium Tremor

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822169


Locations
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Netherlands
Stichting Wageningen Research
Wageningen, Gelderland, Netherlands, 6708 WG
Sponsors and Collaborators
Wageningen University and Research
AAK
Investigators
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Principal Investigator: Diederik Esser, PhD Wageningen University and Research

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Responsible Party: Diederik Esser, project leader clinical trials, Wageningen University and Research
ClinicalTrials.gov Identifier: NCT03822169     History of Changes
Other Study ID Numbers: NL67054.081.18
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents