CompletedNCT02274883Updated Sep 1, 2017

The Effect of Feeding Infant Formula With Enriched Protein Fractions

An interventional study of Enriched Protein Fractions and Protein Fractions in Cognitive Ability, General, sponsored by Mead Johnson Nutrition. Completed at 3 sites in China. Open to participants aged 10 Days to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Mead Johnson Nutrition · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 451
Allocation: Randomized
Ages: 10 Days to 14 Days
Sex: All

Study summary

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 studied

Cognitive Ability, General

In context

Lead sponsor

Mead Johnson Nutrition is the lead sponsor of 56 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 10 Days to 14 Days
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 451 participants (actual)

Study arms

Experimental
Enriched Protein Fractions
This group is given Infant formula with enriched protein fractions.
Dietary Supplement: Enriched Protein Fractions
Active comparator
Protein Fractions
This group is given Infant formula with protein fractions.
Dietary Supplement: Protein Fractions

Interventions

Dietary supplementEnriched Protein Fractions
Enriched protein fractions
Dietary supplementProtein Fractions
Protein fractions

What researchers measure

Primary outcomes

Infant cognitive development
Cognitive Scale of Bayley-III is used as the assessment tool.
Time frame: At 12 months of age

Secondary outcomes

Infant cognitive development
Cognitive Scale of Bayley-III is used as the assessment tool.
Time frame: 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.
Time frame: 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.
Time frame: At 4, 6, 9, 12 and 18 months of age
Infant temperament
Carey Scale is used as assessment tool.
Time frame: At 12 and 18 months of age
Infant attention capabilities
Single Object Attention and Free Play Tasks is used as assessment tool.
Time frame: At 12 and 18 months of age
Physical development
Body weight, length and head circumference are measured.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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

Study locations

3 sites

Fuyang Fifth People's Hospital
Fuyang, Anhui, China
Fuyang Maternal and Child Health Institute
Fuyang, Anhui, China
Yinquan Maternal and Child Health Institute
Fuyang, Anhui, China

References and documents

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 33981943 ↗
Li 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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02274883
Lead sponsor: Mead Johnson Nutrition
Collaborators: Shanghai Children's Medical Center
Responsible party: Sponsor
First posted: Oct 24, 2014
Start date: Nov 2014
Primary completion: Oct 2016
Completion: May 2017
Last update: Sep 1, 2017

Study contacts

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

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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