HealthyNCT02457078
Investigating the Effects of Nutrition on the Maturation of Brain Networks Associated With Memory in Infants
A study testing Postnatal Dietary Supplement in people with Healthy, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
This project will investigate whether adding nutritional supplements to the diet will have beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of age). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Postnatal Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Intention to breast feed for at least the first 3 months
- 18 years of age or older
- Willingness to abstain from multi-vitamins or other supplements that contain lutein and vitamin E during the study and take no more than 200 mg of DHA.
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal hearing
- English is the dominant language spoken in the home.
Who cannot join
- and/or early termination:
- Mother is taking cholesterol medication and/or medication affecting lipid absorption and/or transport.
- High risk pregnant mothers
- Macular Pigment Optical Density (MPOD) score greater than 0.6.
- Preterm birth (less than 37 weeks)
- Low birth weight (less than 2500 grams, < 5.5 pounds)
- Unable or unwilling to continue breast feeding within the first 3 months after birth.
- Unable or unwilling to continue taking the study supplement within the first 3 months after birth.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Beckman Institute
Urbana, Illinois, 61801
Andrew Dinsmoor, BS, 217-244-1619, cnl-subjects@illinois.edu
Kathy Low, PhD, 217-300-6719, lowka@illinois.edu
About this study
Official title: Investigating the Effects of Nutrition on the Maturation of Brain Networks Associated With Memory and Language in Infants
This project will investigate whether adding nutritional supplements to the diet will have beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of age). The nutritional supplement will contain lutein (typically found in leafy vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such as salmon or tuna), and of vitamin E.
Read the detailed description
This project will investigate whether adding nutritional supplements to the diet will have beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of age). The nutritional supplement will contain lutein (typically found in leafy vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such as salmon or tuna), and of vitamin E. This supplement will be taken orally, once a day for 9-10 months starting immediately after delivery. The investigators will also collect a dry blood spot (DBS) from the heel of the infant at 4 and 9 months of age to assess the amount of these nutrients reaching the infants' blood. At these same ages, the investigators will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.
- Conditions
- Healthy
- Being tested
- Postnatal Dietary Supplement, Control Supplement
- Keywords
- nutritional supplements, lutein, DHA, vitamin E, infant brain development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postnatal Dietary SupplementDietary supplement
Dietary Supplement: docosahexaenoic acid, lutein, and α-tocopherol (vitamin E). 1 capsule per day will be consumed beginning immediately after birth and continuing for 9 months.
Control SupplementDietary supplement
Placebo Supplement:soybean oil and α-tocopherol (vitamin E)
| Study group | Role | What they receive |
|---|---|---|
| Postnatal Dietary Supplement | Experimental | Dietary Supplement: docosahexaenoic acid, lutein, and α-tocopherol (vitamin E). 1 capsule per day will be consumed beginning immediately after birth and continuing for 9 months. Receives: Dietary Supplement: Postnatal Dietary Supplement |
| Control Supplement | Placebo comparator | Control Supplement: Capsule containing soybean oil and α-tocopheryl (vitamin E). 1 capsule per day will be consumed beginning immediately after birth and continuing for 9 months. Receives: Dietary Supplement: Control Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Imaging (Event-Related Optical Signal) of breastfed 4 month old infant
The current project will investigate whether nutritional supplements will have beneficial effects on infant brain networks at 4 months of age. We will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.
Measured: Brain activity will be assessed at 4 months of age
Brain Imaging (Event-Related Optical Signal) of breastfed 9 month old infant
The current project will investigate whether nutritional supplements will have beneficial effects on infant brain networks at 9 months of age. We will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.
Measured: Brain activity will be assessed at 9 months of age
Secondary outcomes (2)
Infant Dry Blood Spot at 4 months
We will also collect a dry blood spot (DBS) from the heel of the infant at 4 months of age to assess the amount of the nutrients reaching the infants' blood.
Measured: 4 months of age
Infant Dry Blood Spot at 9 months
We will also collect a dry blood spot (DBS) from the heel of the infant at 9 months of age to assess the amount of the nutrients reaching the infants' blood.
Measured: 9 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriele Gratton, Ph.D., M.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457078
- Sponsor's protocol ID
- ANGC1401
- Status last verified
- May 2017
- First submitted
- 5 Feb 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sherry CL, Oliver JS, Renzi LM, Marriage BJ. Lutein supplementation increases breast milk and plasma lutein concentrations in lactating women and infant plasma concentrations but does not affect other carotenoids. J Nutr. 2014 Aug;144(8):1256-63. doi: 10.3945/jn.114.192914. Epub 2014 Jun 4.
PubMed 24899160Gratton G, Fabiani M. Fast optical imaging of human brain function. Front Hum Neurosci. 2010 Jun 23;4:52. doi: 10.3389/fnhum.2010.00052. eCollection 2010.
PubMed 20631845
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Nutrition on the Maturation of Brain Networks Associated With Memory and Language in Infants
- ClinicalTrials.gov ID
- NCT02457078
- Acronym / sponsor ID
- ANGC1401
- Conditions
- Healthy
- Keywords
- nutritional supplements, lutein, DHA, vitamin E, infant brain development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 May 2015 (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.
This project will investigate whether adding nutritional supplements to the diet will have beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of age). The nutritional supplement will contain lutein (typically found in leafy vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such as salmon or tuna), and of vitamin E.
Detailed description
This project will investigate whether adding nutritional supplements to the diet will have beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of age). The nutritional supplement will contain lutein (typically found in leafy vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such as salmon or tuna), and of vitamin E. This supplement will be taken orally, once a day for 9-10 months starting immediately after delivery. The investigators will also collect a dry blood spot (DBS) from the heel of the infant at 4 and 9 months of age to assess the amount of these nutrients reaching the infants' blood. At these same ages, the investigators will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postnatal Dietary Supplement | Experimental | Dietary Supplement: Postnatal Dietary SupplementDietary Supplement: docosahexaenoic acid, lutein, and α-tocopherol (vitamin E). 1 capsule per day will be consumed beginning immediately after birth and continuing for 9 months. |
| Control Supplement | Placebo comparator | Dietary Supplement: Control SupplementControl Supplement: Capsule containing soybean oil and α-tocopheryl (vitamin E). 1 capsule per day will be consumed beginning immediately after birth and continuing for 9 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (8 listed)
- and/or early termination:
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 |
|---|---|---|
| Postnatal Dietary SupplementDietary Supplement: docosahexaenoic acid, lutein, and α-tocopherol (vitamin E). 1 capsule per day will be consumed beginning immediately after birth and continuing for 9 months. | Dietary supplement | Postnatal Dietary Supplement |
| Control SupplementPlacebo Supplement:soybean oil and α-tocopherol (vitamin E) | Dietary supplement | Control Supplement |
Primary outcome
Brain Imaging (Event-Related Optical Signal) of breastfed 4 month old infant
Time frame: Brain activity will be assessed at 4 months of age
The current project will investigate whether nutritional supplements will have beneficial effects on infant brain networks at 4 months of age. We will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.
Brain Imaging (Event-Related Optical Signal) of breastfed 9 month old infant
Time frame: Brain activity will be assessed at 9 months of age
The current project will investigate whether nutritional supplements will have beneficial effects on infant brain networks at 9 months of age. We will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.
2 secondary outcomes
Infant Dry Blood Spot at 4 months
Time frame: 4 months of age
Infant Dry Blood Spot at 9 months
Time frame: 9 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Background: PubMed 24899160Sherry CL, Oliver JS, Renzi LM, Marriage BJ. Lutein supplementation increases breast milk and plasma lutein concentrations in lactating women and infant plasma concentrations but does not affect other carotenoids. J Nutr. 2014 Aug;144(8):1256-63. doi: 10.3945/jn.114.192914. Epub 2014 Jun 4.
- Background: PubMed 20631845Gratton G, Fabiani M. Fast optical imaging of human brain function. Front Hum Neurosci. 2010 Jun 23;4:52. doi: 10.3389/fnhum.2010.00052. eCollection 2010.
- Individual participant dataSharing planned: Undecided
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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.
Gabriele Gratton, Ph.D., M.D. principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postnatal Dietary Supplement in people with Healthy, run by University of Illinois at Urbana-Champaign 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Dinsmoor, B.S. (217-244-1619, dinsmoor@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Imaging (Event-Related Optical Signal) of breastfed 4 month old infant (time frame: Brain activity will be assessed at 4 months of age). The study lists 2 primary outcomes in all. 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 NCT02457078, 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 4 May 2017.