Effect of Fatty Acids on Memory Performance of ToddlersNCT01634776
Behavioral, Genetic, and Epigenetic Implications of Dietary Supplementation With Alpha-linolenic Acid in Humans
A study testing Flaxseed oil and corn oil in people with Effect of Fatty Acids on Memory Performance of Toddlers, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Fatty acids or omega-3s are important in the human diet for brain development. Of the three main omega-3s (alpha-linolenic acid: ALA, 18:3n-3; eicosapentaenoic acid: EPA; 20:5n-3; docosahexaenoic acid: DHA, 22:6n-3), DHA and EPA have been studied extensively and have been shown to be important in brain function. Read more about this study
- Who is it for?
- Ages 16 to 16 monthsHealthy volunteers can take part
- Conditions the study is for
- Effect of Fatty Acids on Memory Performance of Toddlers
- What is being tested?
- Flaxseed oil and corn oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2011
- 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 16 to 16 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 16-month-old toddlers and their natural mothers
- Born fullterm and healthy with no complications
- English as first language
Who cannot join
- Any toddler with a documented neurological or blood disorder will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC at Chapel Hill Nutrition Research Institute
Kannapolis, North Carolina, 28081
About this study
Official title: Behavioral, Genetic, and Epigenetic Implications of Dietary Supplementation With Alpha-linolenic Acid in Humans.
Fatty acids or omega-3s are important in the human diet for brain development. Of the three main omega-3s (alpha-linolenic acid: ALA, 18:3n-3; eicosapentaenoic acid: EPA; 20:5n-3; docosahexaenoic acid: DHA, 22:6n-3), DHA and EPA have been studied extensively and have been shown to be important in brain function. Conversely, little is known about the effects of ALA even though the body can make DHA and EPA from it. Because the rate at which ALA makes DHA and EPA is very slow, ALA is not considered an important source of DHA and EPA. However, in the human diet, ALA is more readily available, more easily consumed, and less expensive relative to animal sources of DHA and EPA. So, it is very important that the investigators explore the effects of supplementation with ALA. It is possible that the ALA to DHA and EPA conversion rate can be altered by methylation, an epigenetic form of gene expression and regulation. In the present study, the investigators will examine memory abilities and genetic baselines in 16-month-olds. The investigators will then supplement their food with ALA or control oil for 4 months. At 20 months, the investigators will collect outcome data on memory, fatty acid status, genetic variations, and methylation. The investigators hypothesize that the ALA supplementation will result in an increase in the rate of ALA to DHA and EPA conversion through methylation and genetic variations and subsequently, memory abilities will improve. The data from this study will be used to design a larger R01 grant.
- Being tested
- Flaxseed oil, corn oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaxseed oilDietary supplement
Families will be asked to mix the contents of one capsule (1200 mg flaxseed oil or 1288 mg corn oil) into a cup of participants' food, twice a day.
corn oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Corn oil | Placebo comparator | 1288 mg/day corn oil Receives: Dietary Supplement: corn oil |
| Flaxseed oil | Experimental | 1200 mg/day flaxseed oil Receives: Dietary Supplement: Flaxseed oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in declarative memory performance
Measured: Baseline, 120 days
Secondary outcomes (2)
Change in fatty acid levels in plasma
Measured: Baseline, 120 days
Stability of methylation of promoter region of FADS2 gene
Measured: Baseline, 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startFeb 2009
- Primary completionJan 2011
- Study completionJan 2011
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 Effect of Fatty Acids on Memory Performance of ToddlersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Cheatham, PhD, University of North Carolina, Chapel Hill
- Investigators
- Carol L Cheatham, Ph.D., Principal investigator, University of North Carolina, Chapel HillMihai D Niculescu, M.D., Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634776
- Sponsor's protocol ID
- 09-0358
- Status last verified
- Mar 2013
- First submitted
- 2 Jul 2012
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheatham CL, Lupu DS, Niculescu MD. Genetic and epigenetic transgenerational implications related to omega-3 fatty acids. Part II: maternal FADS2 rs174575 genotype and DNA methylation predict toddler cognitive performance. Nutr Res. 2015 Nov;35(11):948-55. doi: 10.1016/j.nutres.2015.09.005. Epub 2015 Sep 11.
PubMed 26455892Lupu DS, Cheatham CL, Corbin KD, Niculescu MD. Genetic and epigenetic transgenerational implications related to omega-3 fatty acids. Part I: maternal FADS2 genotype and DNA methylation correlate with polyunsaturated fatty acid status in toddlers: an exploratory analysis. Nutr Res. 2015 Nov;35(11):939-47. doi: 10.1016/j.nutres.2015.09.004. Epub 2015 Sep 10.
PubMed 26439440
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral, Genetic, and Epigenetic Implications of Dietary Supplementation With Alpha-linolenic Acid in Humans.
- ClinicalTrials.gov ID
- NCT01634776
- Acronym / sponsor ID
- 09-0358
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Jul 2012 (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.
Fatty acids or omega-3s are important in the human diet for brain development. Of the three main omega-3s (alpha-linolenic acid: ALA, 18:3n-3; eicosapentaenoic acid: EPA; 20:5n-3; docosahexaenoic acid: DHA, 22:6n-3), DHA and EPA have been studied extensively and have been shown to be important in brain function. Conversely, little is known about the effects of ALA even though the body can make DHA and EPA from it. Because the rate at which ALA makes DHA and EPA is very slow, ALA is not considered an important source of DHA and EPA. However, in the human diet, ALA is more readily available, more easily consumed, and less expensive relative to animal sources of DHA and EPA. So, it is very important that the investigators explore the effects of supplementation with ALA. It is possible that the ALA to DHA and EPA conversion rate can be altered by methylation, an epigenetic form of gene expression and regulation. In the present study, the investigators will examine memory abilities and genetic baselines in 16-month-olds. The investigators will then supplement their food with ALA or control oil for 4 months. At 20 months, the investigators will collect outcome data on memory, fatty acid status, genetic variations, and methylation. The investigators hypothesize that the ALA supplementation will result in an increase in the rate of ALA to DHA and EPA conversion through methylation and genetic variations and subsequently, memory abilities will improve. The data from this study will be used to design a larger R01 grant.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corn oil | Placebo comparator | Dietary Supplement: corn oil1288 mg/day corn oil |
| Flaxseed oil | Experimental | Dietary Supplement: Flaxseed oil1200 mg/day flaxseed oil |
Who may qualify
- Ages
- 16 to 16 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 16-month-old toddlers and their natural mothers
- Born fullterm and healthy with no complications
- English as first language
Key exclusion criteria (1 listed)
- Any toddler with a documented neurological or blood disorder will be excluded.
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 |
|---|---|---|
| Flaxseed oilFamilies will be asked to mix the contents of one capsule (1200 mg flaxseed oil or 1288 mg corn oil) into a cup of participants' food, twice a day. | Dietary supplement | Flaxseed oil |
| corn oil | Dietary supplement | Corn oil |
Primary outcome
Change in declarative memory performance
Time frame: Baseline, 120 days
2 secondary outcomes
Change in fatty acid levels in plasma
Time frame: Baseline, 120 days
Stability of methylation of promoter region of FADS2 gene
Time frame: Baseline, 120 days
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 5 Mar 2013.
- Derived from this study: PubMed 26455892Cheatham CL, Lupu DS, Niculescu MD. Genetic and epigenetic transgenerational implications related to omega-3 fatty acids. Part II: maternal FADS2 rs174575 genotype and DNA methylation predict toddler cognitive performance. Nutr Res. 2015 Nov;35(11):948-55. doi: 10.1016/j.nutres.2015.09.005. Epub 2015 Sep 11.
- Derived from this study: PubMed 26439440Lupu DS, Cheatham CL, Corbin KD, Niculescu MD. Genetic and epigenetic transgenerational implications related to omega-3 fatty acids. Part I: maternal FADS2 genotype and DNA methylation correlate with polyunsaturated fatty acid status in toddlers: an exploratory analysis. Nutr Res. 2015 Nov;35(11):939-47. doi: 10.1016/j.nutres.2015.09.004. Epub 2015 Sep 10.
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.
Carol L Cheatham, Ph.D. principal investigator
University of North Carolina, Chapel Hill
Mihai D Niculescu, M.D., Ph.D. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed oil and corn oil in people with Effect of Fatty Acids on Memory Performance of Toddlers, run by University of North Carolina, Chapel Hill 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 3 inclusion and 1 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 5 Mar 2013. 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?
Change in declarative memory performance (time frame: Baseline, 120 days). 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 NCT01634776, 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 5 Mar 2013.