Effect of a Multinutrient-Optimized Infant Formula Supplemented With Human Milk Oligosaccharides on Infant Growth and Development: A Multicenter, Randomized, Controlled Trial

Summary

This study aims to learn about a newly developed infant formula that adds two special ingredients found in breast milk (human milk oligosaccharides, HMOs) and improves other nutrients. We will compare the effects of this new formula, a currently available standard formula, and breastfeeding on babies' growth and development during their first year of life. We plan to enroll about 240 healthy newborn babies, who will be divided into three groups: about 80 babies will be fed the new formula with added breast milk ingredients, about 80 will receive the standard infant formula, and about 80 will be breastfed by their mothers. Assignment to the formula groups will be done randomly by computer, while families who wish to and are able to breastfeed will join the breastfeeding group. The study will last about 12 months, during which our research team will have 4 visits with the babies at 28 days, 3 months, 6 months, and 12 months of age. At these visits, we will measure the baby's growth (like height, weight, and head size), use internationally recognized tests to check mental and motor development, collect small samples of stool and blood to understand gut health and immune function, and ask parents to fill out short questionnaires about feeding, sleep, fussiness, and the baby's health. Both formulas used in the study meet national food safety standards, and the entire study follows strict ethical rules to protect the privacy and rights of babies and families. Families in the formula groups will receive all study formula for free and receive regular health check-ups from a professional team. The results will help scientists and doctors better understand how to improve infant formula to support healthy baby growth.

Conditions

• Healthy

Interventions

DIETARY_SUPPLEMENT

Human Milk Oligosaccharide-Supplemented, Multi-Nutrient Optimized Infant Formula

This is an investigational infant formula designed to be closer to the nutritional and functional composition of breast milk. It is distinguished by the addition of a specific, proprietary blend of human milk oligosaccharides (HMOs) and a comprehensively optimized nutrient profile. The optimization encompasses multiple key nutrient categories (including proteins, lipids, prebiotics/probiotics, and micronutrients) aimed at supporting infant gut health, immune development, and overall growth.

DIETARY_SUPPLEMENT

Commercially Available Standard Formula

A commercially available standard infant formula, administered as the control. It does not contain the human milk oligosaccharides (HMOs) or other specific nutrient optimizations present in the investigational formula.

DIETARY_SUPPLEMENT

Breast Milk Feeding

Participants are breastfed by their mothers, receiving human breast milk as the sole or primary source of nutrition. It serves as a natural benchmark for comparing growth, development, and health outcomes against infants fed the investigational or standard formulas.

Sponsors & Collaborators

• Heilongjiang Feihe Dairy Co. Ltd.

  lead INDUSTRY

Principal Investigators

• Zhixu Wang · Nanjing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

28 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-11

Primary Completion

2025-12-16

Completion

2025-12-16

Countries

• China

Study Locations