Declarative MemoryNCT02433600
The Effect of Feeding Infant Formula With Enriched Protein Fractions in the US
A study testing Cow's milk-based infant formula and Cow milk-based infant formula with enriched protein fractions in people with Declarative Memory, run by Mead Johnson Nutrition at 1 site in United States.
Trial summary
This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age. Read more about this study
- Who is it for?
- Ages Up to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Declarative Memory
- What is being tested?
- Cow's milk-based infant formula and Cow milk-based infant formula with enriched protein fractions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Oct 2015
- 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 Up to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton, 0-90 days of age at randomization
- Term infant with birth weight of a minimum of 2500 grams
- Receiving at least 75% of the recommended caloric intake from cow's milk-based infant formula
- Parent or legally authorized representative attending study visits reads, understands, and speaks English
- Signed Informed Consent and Protected Health Information authorization
Who cannot join
- History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- Feeding difficulties or formula intolerance
- Infant born small for gestational age
- Infant born from a mother who was diabetic at childbirth
- History of seizures or neurological disorders or infant with known head/brain disease/injury
Trial locations and contacts
1 site in 1 country.
United States1 site
University or North Carolina Nutrition Research Instutite
Kannapolis, North Carolina, 28081
About this study
Official title: The Effect of Feeding Infant Formula With Enriched Protein Fractions
This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.
- Conditions
- Declarative Memory
- Being tested
- Cow's milk-based infant formula, Cow milk-based infant formula with enriched protein fractions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cow's milk-based infant formulaOther
Cow milk-based infant formula with enriched protein fractionsOther
| Study group | Role | What they receive |
|---|---|---|
| Cow's milk-based infant formula | Active comparator | Not described Receives: Other: Cow's milk-based infant formula |
| Cow milk-based infant formula with enriched protein fractions | Experimental | Not described Receives: Other: Cow milk-based infant formula with enriched protein fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequence Recall using 3-dimensional props
Measured: 365 days of age
Secondary outcomes (10)
Electroencephalogram response to stimuli
Measured: 180 days of age
Sequence Recall using 3-dimensional props
Measured: 300 days of age
Infant Behavior Questionnaire Revised, Short
Measured: 240 days of age
MacArthur-Bates Communication Development Inventory
Measured: 365 days of age
Bayley Scales of Infant and Toddler Development, Third Edition
Measured: 365 days of age
Achieved Weight
Measured: 52 weeks
Achieved Length
Measured: 52 weeks
Achieved Head Circumference
Measured: 52 weeks
Formula Intake
Measured: 52 weeks
Medically-confirmed Adverse Events
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Study was terminated due to lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Declarative MemoryStudies 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, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Carol Lynn Berseth, MD, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433600
- Sponsor's protocol ID
- 6035
- Status last verified
- Mar 2016
- First submitted
- 27 Apr 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
PubMed 37929831
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Feeding Infant Formula With Enriched Protein Fractions
- ClinicalTrials.gov ID
- NCT02433600
- Acronym / sponsor ID
- 6035
- Conditions
- Declarative Memory
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to lack of enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 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 study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cow's milk-based infant formula | Active comparator | Other: Cow's milk-based infant formula |
| Cow milk-based infant formula with enriched protein fractions | Experimental | Other: Cow milk-based infant formula with enriched protein fractions |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Singleton, 0-90 days of age at randomization
- Term infant with birth weight of a minimum of 2500 grams
- Receiving at least 75% of the recommended caloric intake from cow's milk-based infant formula
- Parent or legally authorized representative attending study visits reads, understands, and speaks English
- Signed Informed Consent and Protected Health Information authorization
Key exclusion criteria (5 listed)
- History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- Feeding difficulties or formula intolerance
- Infant born small for gestational age
- Infant born from a mother who was diabetic at childbirth
- History of seizures or neurological disorders or infant with known head/brain disease/injury
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 |
|---|---|---|
| Cow's milk-based infant formula | Other | Cow's milk-based infant formula |
| Cow milk-based infant formula with enriched protein fractions | Other | Cow milk-based infant formula with enriched protein fractions |
Primary outcome
Sequence Recall using 3-dimensional props
Time frame: 365 days of age
10 secondary outcomes
Electroencephalogram response to stimuli
Time frame: 180 days of age
Sequence Recall using 3-dimensional props
Time frame: 300 days of age
Infant Behavior Questionnaire Revised, Short
Time frame: 240 days of age
MacArthur-Bates Communication Development Inventory
Time frame: 365 days of age
Bayley Scales of Infant and Toddler Development, Third Edition
Time frame: 365 days of age
Achieved Weight
Time frame: 52 weeks
Achieved Length
Time frame: 52 weeks
Achieved Head Circumference
Time frame: 52 weeks
Formula Intake
Time frame: 52 weeks
Medically-confirmed Adverse Events
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: Study was terminated due to lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Derived from this study: PubMed 37929831Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
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Recruiting
Targeted Transcranial Magnetic Stimulation to Improve Hippocampal-dependent Declarative Memory Abilities
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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.
Carol Lynn Berseth, MD study director
Mead Johnson Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cow's milk-based infant formula and Cow milk-based infant formula with enriched protein fractions in people with Declarative Memory, run by Mead Johnson Nutrition 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Mar 2016. 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. 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 was stopped early (reason given: Study was terminated due to lack of enrollment). Results are not available in the source record.
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?
Sequence Recall using 3-dimensional props (time frame: 365 days 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 NCT02433600, which also lists 1 linked publication.
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 16 Mar 2016.