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Trial record 90 of 164 for:    PEMT

Synergy Between Choline and DHA

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ClinicalTrials.gov Identifier: NCT03194659
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : July 20, 2018
Sponsor:
Collaborators:
Balchem Corporation
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Cornell University

Brief Summary:
The purpose of this study is to determine whether choline supplementation influences the availability of docosahexaenoic acid throughout pregnancy.

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: Choline Not Applicable

Detailed Description:
Metabolic synergy exists between choline, phospholipid, and polyunsaturated fatty acid metabolism. Previous evidence from our laboratory has shown that higher dietary choline intakes increase the amount of docosahexaenoic acid (DHA) incorporated into phosphatidylcholine (PC), as measured by PC-DHA concentrations in circulating erythrocytes. PC-DHA results from the production of PC through the phosphatidyl N-ethanolamine methyltransferase (PEMT) pathway and is critical for exporting fat from the liver to peripheral tissues. We are expanding this work to pregnant women, for whom DHA intake is critical to support the developing infant's growth, by undertaking a double blind, randomized controlled trial of choline supplementation (500mg) throughout the 2nd and 3rd trimesters of pregnancy. All women will consume 200mg of docosahexaenoic acid (DHA), a prenatal vitamin, and 25-50mg of deuterated choline (choline d9) daily throughout the duration of the trial. The use of a stable isotope will allow for modeling of choline dynamics throughout the 2nd and 3rd trimester of pregnancy, and calculate the activity of PEMT in pregnant women. Consenting participants will provide a baseline blood draw, followed by 2 additional blood draws throughout their pregnancies, and maternal/cord blood at birth, in addition to the placenta. This trial will test the hypothesis that choline supplementation increases the amount of PC-DHA in the blood of pregnant women and increase its supply to the developing fetus.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: All investigators interacting with participants will be masked to the study arm assignment. Only the Primary Investigator and Laboratory Manager (prepares supplements) will have access to participant's study assignment.
Primary Purpose: Basic Science
Official Title: Maternal Choline Supplementation and Its Impact on Docosahexaenoic Acid Supply in Human Pregnancy
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Placebo
Administration of the deuterated choline chloride will take place in a grape juice cocktail solution. For individuals in the placebo arm of the trial, no additional choline chloride will be added to the cocktail.
Experimental: Supplemental Choline
Administration of the deuterated choline chloride will take place in a grape juice cocktail solution. For individuals in the placebo arm of the trial, supplemental choline chloride will be added to the cocktail.
Dietary Supplement: Choline
Choline chloride is a water soluble choline salt that will be provided in a juice solution to participants to be consumed daily. The intervention will increase dietary choline intake by 500mg/day.




Primary Outcome Measures :
  1. DHA-Containing Phosphatidylcholine Species in Circulating Erythrocytes [ Time Frame: Gestational Weeks 12-16 through Gestational Weeks 38-41 ]
    Phosphatidylcholine species contain 2 fatty acid tails; phosphatidylcholines containing DHA at either the sn-1 or sn-2 positions are found circulating in erythrocytes and serve as a long term marker of DHA status. Erythrocyte PC-DHA is partially supplied by albumin bound lysophosphatidylcholine enriched with DHA, a product of the phosphatidylethanolamine methyltransferase pathway in the liver . which has been shown to be sensitive to dietary choline intakes in non-pregnant women.


Secondary Outcome Measures :
  1. Circulating labeled and unlabeled choline metabolites in maternal plasma [ Time Frame: Gestational Weeks 12-16 through Gestational Weeks 38-41 ]
    The concentrations and isotopic enrichments of choline and its metabolites (betaine, dimethylglycine,sarcosine, total phosphatidylcholine) will be determined in the maternal, placental and fetal compartments.

  2. The impact of dietary choline on total DHA concentrations in the maternal, fetal and placental compartments [ Time Frame: Gestational Weeks 12-16 through Gestational Weeks 38-41 ]
    The total concentrations of docosahexaenoic acid (DHA) will be measured in the maternal blood throughout this study. Additionally, at term, placenta and cord blood will be collected and analyzed for total DHA measurements.



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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy, singleton pregnant women gestational weeks 12-16, ages 21-40, willingness to comply with the study protocol

Exclusion Criteria:

  • Habitually high choline/DHA intake
  • BMI >32
  • Pregnancy complications and comorbidities (at baseline and throughout the study)
  • Current smokers, drinkers, or drug users

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): NCT03194659


Contacts
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Contact: Marie A. Caudill, PhD 607-254-7456 mac379@cornell.edu
Contact: Kevin C. Klatt 267-978-8889 kck68@cornell.edu

Locations
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United States, New York
Human Metabolic Research Unit, Cornell University Recruiting
Ithaca, New York, United States, 14853
Contact: Erica Bender, MSN, CNM    607-255-9417    eb572@cornell.edu   
Principal Investigator: Marie A. Caudill, PhD         
Sponsors and Collaborators
Cornell University
Balchem Corporation
DSM Nutritional Products, Inc.
Investigators
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Principal Investigator: Marie A. Caudill, PhD Cornell University

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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT03194659     History of Changes
Other Study ID Numbers: IRB #: 1702006936
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

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

Keywords provided by Cornell University:
Nutrition
choline
pregnancy
docosahexaenoic acid
DHA
fatty acids

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