Supplemental Choline and Brain Development in Humans

June 16, 2010 updated by: The Gerber Foundation

Supplemental Choline and Neurodevelopment in Humans

Studies have shown that choline is a necessary part of the human diet. Choline is important in making membranes for all the cells in the body, and for making chemicals that are responsible for nerve function. Studies have also shown that choline improves memory of rats when they are given choline at early stages in their lives. The purpose of this study is to find out whether choline supplementation (provided as a choline dietary supplement) in pregnant women will improve memory function of their babies after they are born.

In this study, we hypothesize that high dietary choline consumption during pregnancy and lactation will:

  1. Increase maternal choline concentration in plasma
  2. Increase breast milk choline concentration
  3. Enhance memory performance in the children born of supplemented mothers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The development of brain during critical periods in embryogenesis is vulnerable to changes in diet, specifically changes in choline intake. Babies born of mothers eating more choline are smarter on memory testing. These effects of dietary choline have been repeatedly demonstrated in rodent models in a series of studies funded by the NIH during the last eight years. Specifically, prenatal choline supplementation in rats facilitates cognitive function and visuospatial memory, whereas choline deficiency impairs divided attention and accelerates the age-related decline in temporal processing. There are two sensitive periods in rat brain development during which treatment with choline produces long-lasting enhancement of spatial memory that is lifelong. The first occurs during embryonic days 12-17 (rats give birth on day 21) and the second, during postnatal days 16-30. Choline supplementation during these critical periods elicits a major improvement in memory performance at all stages of training on a 12-arm radial maze. These changes in memory are correlated with decreases in the threshold for induction of long-term potentiation and with biochemical changes. Choline supplementation in pregnant rats decreases choline acetyltransferase activity and increases phospholipase D (PLD) activity in the hippocampus of offspring. Also, it increases the size of the cell body of cholinergic neurons. In contrast choline deficiency increases the activity of cholinergic system, but does not affect the basal level of PLD activity in hippocampus. These long-lasting functional, anatomical, and biochemical alterations may be related to the changes in neurogenesis and differentiation in fetal hippocampus and septum, areas of brain that are important for normal spatial learning and memory.

It is not known if these findings in rodents are likely to be true in humans, as human and rat brains mature at different rates. Moreover, rat brain is comparatively more mature at birth than is the human brain, but in humans hippocampal development may start around 20 weeks gestation and continue for months after birth. However, everything we know about brain development tells us that the processes seen in rodents are the same as those that occur in the developing human brain. For this reason, it is extremely likely that the robust effects we observe for choline in rodent brain have importance in the human. The research is the first major study in humans to determine whether maternal diet and diet during the baby's first year influences brain function.

Study Type

Interventional

Enrollment (Actual)

150

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
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Less than 18 weeks pregnant
  • Intends to breastfeed
  • Receives regular prenatal care
  • Takes a prenatal vitamin

Exclusion Criteria:

  • Uses tobacco or illicit drugs
  • Consumes alcohol
  • History of chronic illness
  • History of allergy to soy or corn
  • Difficulty swallowing large capsules
  • BMI <18 or >35
  • Pregnant with more than 1 fetus

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Choline supplement given from 18-weeks pregnancy through 90 days postpartum
Dietary supplement: Phosphatidylcholine
850 mg per day from 18 weeks pregnancy through 90 days postpartum
Other Names:
  • PhosChol
Placebo Comparator: 2
Placebo capsules given from 18 weeks pregnancy through 90 days postpartum
Dietary supplement: Corn oil placebo
Placebo capsules containing corn oil given from 18 weeks pregnancy through 90 days postpartum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infant working memory
Time Frame: 10 months & 12 months of age
10 months & 12 months of age

Secondary Outcome Measures

Outcome Measure
Time Frame
Breast milk choline concentration
Time Frame: 45 & 90 days postpartum
45 & 90 days postpartum
Plasma choline concentrations
Time Frame: 20 & 30 wks pregnancy, 45 & 90 days postpartum
20 & 30 wks pregnancy, 45 & 90 days postpartum

Collaborators and Investigators

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

Sponsor

The Gerber Foundation

Collaborators

Egg Nutrition Center

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

December 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (Estimate)

May 16, 2008

Study Record Updates

Last Update Posted (Estimate)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 16, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 04-1752 (completed)

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.

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