Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants

NCT ID: NCT04749290

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-02-15

Brief Summary

The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary objective is to compare the growth, tolerance, stool consistency and bone strength of infants randomized to the study infant formula (SF) versus infants randomized to the standard commercial infant formula (CF).

Detailed Description

This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a study infant formula, formulated for healthy term infants or a commercially available infant formula for healthy term infants. Infants will consume the formula for a total of 16-weeks; infant growth, tolerance, stool consistency and bone strength will be assessed throughout the study.

Conditions

Infant Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Study Formula

a Cow's Milk Based Infant Formula Containing Both OPO and CPP for term infants (JunLeBao ZhiZhen)

Group Type: EXPERIMENTAL

Study Formula

Intervention Type: OTHER

Study infant formula for term infants containing OPO and CPP

Comparator Formula

Commercially available infant formula without OPO for term infants (JunLeBao LeChun)

Group Type: ACTIVE_COMPARATOR

Study Formula

Intervention Type: OTHER

Study infant formula for term infants containing OPO and CPP

Human Milk Reference Group

Human milk

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Study Formula

Study infant formula for term infants containing OPO and CPP

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 30 days of age at randomization, inclusive (day of birth is considered day 0)
• Exclusively formula-fed or partially bottle feeding with intake more than 650 ml /day for at least 3 days prior to randomization
• Exclusively breast fed for at least 7 days prior to randomization
• Singleton birth
• Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks of gestational age)
• Birth weight of 2500g to 4000g
• Signed informed consent obtained for infant's participation in the study
• Parent or guardian of infant agrees not to enroll infant in another interventional clinical research study while participating in this study

Exclusion Criteria

• History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
• Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
• Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%]
• Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others
• Participation in another clinical trial
• Known or increased risk of cow's milk allergy and/ or lactose intolerance (i.e. one of the biological parents and or siblings diagnosed with cow's milk allergy, asthma, hay fever, etc.)
• Having a mother suffering from diabetes during pregnancy
• Use of antibiotics at the time of screening, or during the past two weeks

• Minimum Eligible Age: 14 Days
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Junlebao Dairy Group Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sprim Advanced Life Sciences

OTHER

Sponsor Role: collaborator

Bunge Loders Croklaan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoyang Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

JiangNan Street Community Health Service Center, WuCheng District

Jinhua, , China

QiuBin Street Community Health Service Center, WuCheng District

Jinhua, , China

Countries

China

References

Sheng XY, Mi W, Yuan QB, Liu BY, Carnielli V, Ning YB, Einerhand AWC. An A2 beta-casein infant formula with high sn-2 palmitate and casein phosphopeptides supports adequate growth, improved stool consistency, and bone strength in healthy, term Chinese infants: a randomized, double-blind, controlled clinical trial. Front Nutr. 2024 Aug 14;11:1442584. doi: 10.3389/fnut.2024.1442584. eCollection 2024.

Reference Type: DERIVED

PMID: 39206307 (View on PubMed)

Other Identifiers

20-SM-09-Bunge-001

Identifier Type: -

Identifier Source: org_study_id