Cognitive Ability, GeneralNCT02274883
The Effect of Feeding Infant Formula With Enriched Protein Fractions
A study testing Enriched Protein Fractions and Protein Fractions in people with Cognitive Ability, General, run by Mead Johnson Nutrition at 3 sites in China.
Trial summary
This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes. Read more about this study
- Who is it for?
- Ages 10 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Cognitive Ability, General
- What is being tested?
- Enriched Protein Fractions and Protein Fractions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 3 sitesChina
- Study dates
- Nov 2014to May 2017
- 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 10 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 10-14 days of age
- Exclusively formula-fed
- Singleton birth
- Gestational age of 37-42 weeks
- Birth weight of 2500g to 4000g
- Signed Informed Consent Form
Who cannot join
- History of underlying metabolic or chronic disease
- Congenital malformation
- Condition which is likely to interfere with food ingestion, normal growth, development and evaluation
- Evidence of feeding difficulties or intolerance
- Immunocompromised
- Head/brain disease/injury
Trial locations and contacts
3 sites in 1 country.
China3 sites
Fuyang Fifth People's Hospital
Fuyang, Anhui
Fuyang Maternal and Child Health Institute
Fuyang, Anhui
Yinquan Maternal and Child Health Institute
Fuyang, Anhui
About this study
This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
Read the detailed description
To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
- Conditions
- Cognitive Ability, General
- Being tested
- Enriched Protein Fractions, Protein Fractions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched Protein FractionsDietary supplement
Enriched protein fractions
Protein FractionsDietary supplement
Protein fractions
| Study group | Role | What they receive |
|---|---|---|
| Enriched Protein Fractions | Experimental | This group is given Infant formula with enriched protein fractions. Receives: Dietary Supplement: Enriched Protein Fractions |
| Protein Fractions | Active comparator | This group is given Infant formula with protein fractions. Receives: Dietary Supplement: Protein Fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant cognitive development
Cognitive Scale of Bayley-III is used as the assessment tool.
Measured: At 12 months of age
Secondary outcomes (10)
Infant cognitive development
Cognitive Scale of Bayley-III is used as the assessment tool.
Measured: At 18 months of age
Infant language and motor skills
Ages and Stages Questionnaire, MacArthur-Bates Communicative Development Index, Language Scale and Motor Scale of Bayley-III are used as the assessment tool.
Measured: At 4, 6, 9, 12 and 18 months of age
Infant acquisition of social and emotional milestones and adaptive development
Ages and Stages Questionnaire, social-emotional scale and adaptive behavior scale of Bayley-III are used as assessment tool.
Measured: At 4, 6, 9, 12 and 18 months of age
Infant temperament
Carey Scale is used as assessment tool.
Measured: At 12 and 18 months of age
Infant attention capabilities
Single Object Attention and Free Play Tasks is used as assessment tool.
Measured: At 12 and 18 months of age
Physical development
Body weight, length and head circumference are measured.
Measured: At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age
Stool characteristics
According to the recall of parents during the last 24 hours.
Measured: At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age
Formula intake
According to the recall of parents during the last 24 hours.
Measured: At 30, 42, 60, 90, 120, 180, 275 and 365 days of age
Fecal microbiome and metabolome profile
Fecal microbiome analysis is done at average of 14 days and 120 days of age. While metabolome profile analysis is done at only average of 120 days of age.
Measured: Average of 14 days of age and 120 days of age
Medically-confirmed Adverse Events
Measured: Up to 19 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 posted24 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2016
- Study completionMay 2017
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 Cognitive Ability, GeneralStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Medical Center
- Responsible party
- Sponsor
- Investigators
- John Colombo, Doctor, Study chair, University of KansasFei Li, Doctor, Study chair, Shanghai Children's Medical CenterBryan Liu, Doctor, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274883
- Sponsor's protocol ID
- 6027
- Status last verified
- Aug 2017
- First submitted
- 16 Oct 2014
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chichlowski M, Bokulich N, Harris CL, Wampler JL, Li F, Berseth CL, Rudolph C, Wu SS. Effect of Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula on Gut Microbiome and Metabolome at 4 Months of Age. Curr Dev Nutr. 2021 Apr 2;5(5):nzab027. doi: 10.1093/cdn/nzab027. eCollection 2021 May.
PubMed 33981943Li F, Wu SS, Berseth CL, Harris CL, Richards JD, Wampler JL, Zhuang W, Cleghorn G, Rudolph CD, Liu B, Shaddy DJ, Colombo J. Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial. J Pediatr. 2019 Dec;215:24-31.e8. doi: 10.1016/j.jpeds.2019.08.030. Epub 2019 Oct 24.
PubMed 31668885
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. 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
- NCT02274883
- Acronym / sponsor ID
- 6027
- Conditions
- Cognitive Ability, General
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Medical Center
- Study start
- Nov 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Oct 2014 (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 evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
Detailed description
To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enriched Protein Fractions | Experimental | Dietary Supplement: Enriched Protein FractionsThis group is given Infant formula with enriched protein fractions. |
| Protein Fractions | Active comparator | Dietary Supplement: Protein FractionsThis group is given Infant formula with protein fractions. |
Who may qualify
- Ages
- 10 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 10-14 days of age
- Exclusively formula-fed
- Singleton birth
- Gestational age of 37-42 weeks
- Birth weight of 2500g to 4000g
Key exclusion criteria (6 listed)
- History of underlying metabolic or chronic disease
- Congenital malformation
- Condition which is likely to interfere with food ingestion, normal growth, development and evaluation
- Evidence of feeding difficulties or intolerance
- Immunocompromised
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 |
|---|---|---|
| Enriched Protein FractionsEnriched protein fractions | Dietary supplement | Enriched Protein Fractions |
| Protein FractionsProtein fractions | Dietary supplement | Protein Fractions |
Primary outcome
Infant cognitive development
Time frame: At 12 months of age
Cognitive Scale of Bayley-III is used as the assessment tool.
10 secondary outcomes
Infant cognitive development
Time frame: At 18 months of age
Infant language and motor skills
Time frame: At 4, 6, 9, 12 and 18 months of age
Infant acquisition of social and emotional milestones and adaptive development
Time frame: At 4, 6, 9, 12 and 18 months of age
Infant temperament
Time frame: At 12 and 18 months of age
Infant attention capabilities
Time frame: At 12 and 18 months of age
Physical development
Time frame: At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age
Stool characteristics
Time frame: At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age
Formula intake
Time frame: At 30, 42, 60, 90, 120, 180, 275 and 365 days of age
Fecal microbiome and metabolome profile
Time frame: Average of 14 days of age and 120 days of age
Medically-confirmed Adverse Events
Time frame: Up to 19 months of age
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 1 Sep 2017.
- Derived from this study: PubMed 33981943Chichlowski M, Bokulich N, Harris CL, Wampler JL, Li F, Berseth CL, Rudolph C, Wu SS. Effect of Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula on Gut Microbiome and Metabolome at 4 Months of Age. Curr Dev Nutr. 2021 Apr 2;5(5):nzab027. doi: 10.1093/cdn/nzab027. eCollection 2021 May.
- Derived from this study: PubMed 31668885Li F, Wu SS, Berseth CL, Harris CL, Richards JD, Wampler JL, Zhuang W, Cleghorn G, Rudolph CD, Liu B, Shaddy DJ, Colombo J. Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial. J Pediatr. 2019 Dec;215:24-31.e8. doi: 10.1016/j.jpeds.2019.08.030. Epub 2019 Oct 24.
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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.
John Colombo, Doctor study chair
University of Kansas
Fei Li, Doctor study chair
Shanghai Children's Medical Center
Bryan Liu, Doctor study director
Mead Johnson Nutrition
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched Protein Fractions and Protein Fractions in people with Cognitive Ability, General, run by Mead Johnson Nutrition at 3 sites in China.
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 6 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 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 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 cognitive development (time frame: At 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 NCT02274883, 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 1 Sep 2017.