Effect of Maternal Choline Intake on Choline Status and Health Biomarkers During Pregnancy and Lactation

September 17, 2013 updated by: Cornell University

Effect of Maternal Choline Intake on Maternal/Fetal Biomarkers of Choline Status

The purpose of this study is to investigate the effect of varied maternal choline intake on maternal/fetal biomarkers of choline status, genomic expression and metabolomic profiling.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Choline is a micronutrient used for the structural integrity of cell membranes, lipid transport/metabolism, methylation reactions and cholinergic neurotransmission. Prenatal and early postnatal choline exposure plays a critical role in brain development and cognition based on animal data. Although it is recognized that choline use is particularly high during pregnancy and lactation, the level of choline intake needed to optimize maternal and fetal health outcomes is unknown. The primary objective of this study was to investigate the metabolic and genomic effects of two doses of choline intake, 450 mg/d (the adequate intake level for pregnant women) and 900 mg/d in pregnant, lactating, and nonpregnant control women. A secondary objective was to examine the effect of extra maternal choline intake on the child's cognitive performance (i.e, learning, memory and attention). To accomplish these objectives, pregnant women (wk 27 gestation), nonpregnant control women, and lactating women consumed controlled choline intakes of 480 or 930 mg/d for 10 to 12 weeks. The basal diet provided 380 mg/d; supplemental choline chloride, 100 or 550 mg/d, was used to achieve the target intake levels. During the last half of the study, a small portion (~ 20%) of the total choline intake was derived from deuterium labeled choline, a stable isotope. Blood, urine and/or breast milk were collected at baseline and at select timepoints throughout the study duration. For pregnant women, a maternal blood sample was obtained at the time of delivery along with a cord blood sample and the placental tissue. Genomic and metabolomic profiling were performed on the collected biological samples along with specific measurements of choline status. Non-invasive tests assessing cognitive function were performed on the children of the pregnant and lactating study participants. This controlled feeding study has also been extended to investigate dose-response relationships for other micronutrients including folate, vitamin B12, vitamin D, and biotin.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Ithaca, New York, United States, 14853
        • Human Metabolic Research Unit, Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant (wk 27 gestation) or lactating (postnatal day 30) or nonpregnant
  • Healthy
  • Non-smoker

Exclusion Criteria:

  • Liver or kidney problems
  • Alcohol or illegal drug misuse/abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 480 mg/d choline intake
480 mg/d choline derived from the diet [380 mg choline/d] plus supplemental choline chloride [100 mg choline/d]
Dietary supplement: choline chloride
Women will consume a diet providing 380 mg/d total choline plus 100 mg/d supplemental choline [from choline chloride] for a total choline intake of 480 mg/d. The choline chloride will be administered in cran-grape juice.
Experimental: 930 mg/d choline intake
930 mg/d choline derived from the diet [380 mg choline/d] plus supplemental choline chloride [550 mg choline/d]
Dietary supplement: Choline Chloride
Women will consume a diet providing 380 mg/d total choline plus 550 mg/d supplemental choline [from choline chloride] for a total choline intake of 930 mg/d. The choline chloride will be administered in cran-grape juice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maternal biomarkers of choline status
Time Frame: 10-12 Weeks
10-12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Genomic expression as function of maternal choline intake
Time Frame: 10-12 Weeks
10-12 Weeks
Cognitive performance in children of study participants
Time Frame: 12 months
12 months
Metabolomic profiling as a function of maternal choline intake
Time Frame: 10-12 Weeks
10-12 Weeks
Biomarkers for additional micronutrients
Time Frame: 10-12 Weeks
10-12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornell University

Collaborators

USDA Beltsville Human Nutrition Research Center
National Cattlemen's Beef Association
American Egg Board

Investigators

  • Principal Investigator: Marie A Caudill, PhD, RD, Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 19, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 17, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSP No: 59370, 57100, 58222

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy

Clinical Trials on choline chloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe