Clinical trial NCT03194659: Synergy Between Choline and DHA
Official title: Maternal Choline Supplementation and Its Impact on Docosahexaenoic Acid Supply in Human Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: Nutrition
choline
pregnancy
docosahexaenoic acid
DHA
fatty acids
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Balchem Corporation
First posted: 2017-06-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility 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
* Pre-pregnancy BMI \>32
* Pregnancy complications and comorbidities (at baseline and throughout the study)
* Current smokers, drinkers, or drug users

Primary outcomes:
measure: DHA-Containing Phosphatidylcholine Species in Circulating Erythrocytes
timeFrame: Gestational Weeks 12-16 through Gestational Weeks 38-41
Secondary outcomes:
measure: Circulating labeled and unlabeled choline metabolites in maternal plasma
timeFrame: Gestational Weeks 12-16 through Gestational Weeks 38-41
measure: The impact of dietary choline on total DHA concentrations in the maternal, fetal and placental compartments
timeFrame: Gestational Weeks 12-16 through Gestational Weeks 38-41
measure: The Association of Maternal Choline Supplementation with Infant Visual Recognition Memory Novelty Score
timeFrame: 5, 7, 10, and 13 months of age
measure: The Association of Maternal Choline Supplementation with Infant Visual Attention Orienting Speed Score
timeFrame: 5, 7, 10, and 13 months of age
measure: The Association of Maternal Choline Supplementation with Infant Sustained Focused Attention Score
timeFrame: 5, 7, 10, and 13 months of age
measure: The Association of Maternal Choline Supplementation with Infant Recall Memory Score
timeFrame: 13 months of age
Other outcomes:
measure: Maternal choline intake and microbiome composition
timeFrame: Gestational Weeks 12-16 through Gestational Weeks 38-41 and neonatal month 3
Locations:
city: Ithaca
country: United States
facility: Human Metabolic Research Unit, Cornell University
state: New York
Study officials:
affiliation: Cornell University
name: Marie A. Caudill, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klatt KC, McDougall MQ, Malysheva OV, Taesuwan S, Loinard-Gonzalez AAP, Nevins JEH, Beckman K, Bhawal R, Anderson E, Zhang S, Bender E, Jackson KH, King DJ, Dyer RA, Devapatla S, Vidavalur R, Brenna JT, Caudill MA. Prenatal choline supplementation improves biomarkers of maternal docosahexaenoic acid (DHA) status among pregnant participants consuming supplemental DHA: a randomized controlled trial. Am J Clin Nutr. 2022 Sep 2;116(3):820-832. doi: 10.1093/ajcn/nqac147.