Synergy Between Choline and DHA
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|ClinicalTrials.gov Identifier: NCT03194659|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Dietary Supplement: Choline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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 :||December 5, 2021|
|Estimated Study Completion Date :||December 5, 2021|
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 experimental 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.
- 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.
- 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 by Liquid Chromatography Tandem Mass Spectrometry
- 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; % total fatty acids as determined by Gas Chromatography-Flame Ionization Detector) 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.
- The Association of Maternal Choline Supplementation with Infant Visual Recognition Memory Novelty Score [ Time Frame: 5, 7, 10, and 13 months of age ]The composite novelty score (proportion of looking to the novel image) is obtained from a series of 9 visual paired comparison tests. The novelty score is a measure of visual recognition memory for infants and has been shown to predict cognitive outcomes in childhood.
- The Association of Maternal Choline Supplementation with Infant Visual Attention Orienting Speed Score [ Time Frame: 5, 7, 10, and 13 months of age ]Visual attention orienting speed is measured by the latency to initiate a stimulus-guided fixation shift to a peripheral visual target (mean of up to 20 target presentations). The orienting score was found to be sensitive to maternal choline supplementation in infants of this age and has shown acceptable test-retest reliability and prediction of attention, memory, and intelligence quotient outcomes in childhood.
- The Association of Maternal Choline Supplementation with Infant Sustained Focused Attention Score [ Time Frame: 5, 7, 10, and 13 months of age ]Sustained focused attention is measured during a 5-minute period in which infants are engaged in solitary play with a complex toy. The score is the average duration of infant engagement in a state of focused attention on the toy. Infants who sustain focused attention for longer durations have been found to have fewer attentional problems as children.
- The Association of Maternal Choline Supplementation with Infant Recall Memory Score [ Time Frame: 13 months of age ]Recall memory is measured with a deferred imitation protocol. The infant watches an adult perform a novel sequence of actions on a set of objects to produce an interesting result. After a distraction-filled 15-minute delay the infant is given the objects and encouraged to engage in the modeled actions. The score is the number of target actions reproduced (average of 3 problems). Infants who achieve greater recall memory scores perform better on tests of memory during childhood.
- Maternal choline intake and microbiome composition [ Time Frame: Gestational Weeks 12-16 through Gestational Weeks 38-41 and neonatal month 3 ]Assess the effect of maternal choline intake during pregnancy on the maternal and neonatal gut microbiome, and the effect of the maternal microbiome on biomarkers of maternal status.
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
|Contact: Marie A. Caudill, PhD, RDemail@example.com|
|Contact: Kevin C. Klatt, PhD, RDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Marie A. Caudill, PhD, RD|
|Principal Investigator:||Marie A. Caudill, PhD, RD||Cornell University|