Synergy Between Choline and DHA

NCT03194659 | Unknown

• 1 other identifier: IRB #: 1702006936
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy

Keywords

Nutrition; choline; pregnancy; docosahexaenoic acid; DHA; fatty acids

Outcome Measures

Primary Outcomes (1)

• DHA-Containing Phosphatidylcholine Species in Circulating Erythrocytes

  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.

  Gestational Weeks 12-16 through Gestational Weeks 38-41

Secondary Outcomes (6)

• Circulating labeled and unlabeled choline metabolites in maternal plasma

  Gestational Weeks 12-16 through Gestational Weeks 38-41

• The impact of dietary choline on total DHA concentrations in the maternal, fetal and placental compartments

  Gestational Weeks 12-16 through Gestational Weeks 38-41

• The Association of Maternal Choline Supplementation with Infant Visual Recognition Memory Novelty Score

  5, 7, 10, and 13 months of age

• The Association of Maternal Choline Supplementation with Infant Visual Attention Orienting Speed Score

  5, 7, 10, and 13 months of age

• The Association of Maternal Choline Supplementation with Infant Sustained Focused Attention Score

  5, 7, 10, and 13 months of age

Other Outcomes (1)

• Maternal choline intake and microbiome composition

  Gestational Weeks 12-16 through Gestational Weeks 38-41 and neonatal month 3

Study Arms (2)

Placebo

NO INTERVENTION

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.

Supplemental Choline

EXPERIMENTAL

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

Interventions

Choline DIETARY_SUPPLEMENT

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.

Supplemental Choline

Eligibility Criteria

• Age: 21 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornell University: lead
• Balchem Corporation: collaborator

Study Sites (1)

Human Metabolic Research Unit, Cornell University

Ithaca, New York, 14853, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35575618 DERIVED

MeSH Terms

Interventions

Choline

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• Marie A. Caudill, PhD, RD

  Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie A. Caudill, PhD, RD

CONTACT

607-254-7456; mac379@cornell.edu

Kevin C. Klatt, PhD, RD

CONTACT

267-978-8889; klatt@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 21, 2017
• Study Start: October 5, 2017
• Primary Completion: December 5, 2021
• Study Completion: December 5, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)