HealthyNCT00678925
Supplemental Choline and Brain Development in Humans
A study testing Phosphatidylcholine in people with Healthy, run by The Gerber Foundation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Phosphatidylcholine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Less than 18 weeks pregnant
- Intends to breastfeed
- Receives regular prenatal care
- Takes a prenatal vitamin
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27514
About this study
Official title: 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:
- Increase maternal choline concentration in plasma
- Increase breast milk choline concentration
- Enhance memory performance in the children born of supplemented mothers
Read the 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.
- Conditions
- Healthy
- Being tested
- Phosphatidylcholine, Corn oil placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhosphatidylcholineDietary supplement
Also called PhosChol
850 mg per day from 18 weeks pregnancy through 90 days postpartum
Corn oil placeboDietary supplement
Placebo capsules containing corn oil given from 18 weeks pregnancy through 90 days postpartum
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Choline supplement given from 18-weeks pregnancy through 90 days postpartum Receives: Dietary Supplement: Phosphatidylcholine |
| 2 | Placebo comparator | Placebo capsules given from 18 weeks pregnancy through 90 days postpartum Receives: Dietary Supplement: Corn oil placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant working memory
Measured: 10 months & 12 months of age
Secondary outcomes (2)
Breast milk choline concentration
Measured: 45 & 90 days postpartum
Plasma choline concentrations
Measured: 20 & 30 wks pregnancy, 45 & 90 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startDec 2004
- Primary completionDec 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Gerber Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Egg Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678925
- Sponsor's protocol ID
- 04-1752 (completed)
- Status last verified
- Jun 2010
- First submitted
- 14 May 2008
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheatham CL, Goldman BD, Fischer LM, da Costa KA, Reznick JS, Zeisel SH. Phosphatidylcholine supplementation in pregnant women consuming moderate-choline diets does not enhance infant cognitive function: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2012 Dec;96(6):1465-72. doi: 10.3945/ajcn.112.037184. Epub 2012 Nov 7.
PubMed 23134891Fischer LM, da Costa KA, Galanko J, Sha W, Stephenson B, Vick J, Zeisel SH. Choline intake and genetic polymorphisms influence choline metabolite concentrations in human breast milk and plasma. Am J Clin Nutr. 2010 Aug;92(2):336-46. doi: 10.3945/ajcn.2010.29459. Epub 2010 Jun 9.
PubMed 20534746
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Choline and Neurodevelopment in Humans
- ClinicalTrials.gov ID
- NCT00678925
- Acronym / sponsor ID
- 04-1752 (completed)
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Gerber FoundationUniversity, hospital or other
- Collaborators
- Egg Nutrition Center
- Study start
- Dec 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 16 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Increase maternal choline concentration in plasma
- Increase breast milk choline concentration
- Enhance memory performance in the children born of supplemented mothers
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: PhosphatidylcholineCholine supplement given from 18-weeks pregnancy through 90 days postpartum |
| 2 | Placebo comparator | Dietary Supplement: Corn oil placeboPlacebo capsules given from 18 weeks pregnancy through 90 days postpartum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Less than 18 weeks pregnant
- Intends to breastfeed
- Receives regular prenatal care
- Takes a prenatal vitamin
Key exclusion criteria (7 listed)
- Uses tobacco or illicit drugs
- Consumes alcohol
- History of chronic illness
- History of allergy to soy or corn
- Difficulty swallowing large capsules
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhosphatidylcholineAlso: PhosChol850 mg per day from 18 weeks pregnancy through 90 days postpartum | Dietary supplement | 1 |
| Corn oil placeboPlacebo capsules containing corn oil given from 18 weeks pregnancy through 90 days postpartum | Dietary supplement | 2 |
Primary outcome
Infant working memory
Time frame: 10 months & 12 months of age
2 secondary outcomes
Breast milk choline concentration
Time frame: 45 & 90 days postpartum
Plasma choline concentrations
Time frame: 20 & 30 wks pregnancy, 45 & 90 days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Derived from this study: PubMed 23134891Cheatham CL, Goldman BD, Fischer LM, da Costa KA, Reznick JS, Zeisel SH. Phosphatidylcholine supplementation in pregnant women consuming moderate-choline diets does not enhance infant cognitive function: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2012 Dec;96(6):1465-72. doi: 10.3945/ajcn.112.037184. Epub 2012 Nov 7.
- Derived from this study: PubMed 20534746Fischer LM, da Costa KA, Galanko J, Sha W, Stephenson B, Vick J, Zeisel SH. Choline intake and genetic polymorphisms influence choline metabolite concentrations in human breast milk and plasma. Am J Clin Nutr. 2010 Aug;92(2):336-46. doi: 10.3945/ajcn.2010.29459. Epub 2010 Jun 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phosphatidylcholine in people with Healthy, run by The Gerber Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant working memory (time frame: 10 months & 12 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00678925, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2010.