The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants

NCT06256094 | Completed DMC

• 1 other identifier: A2220616005
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, prospective study to evaluate the nutritive effects of an a2 infant formula on growth and tolerance in healthy term infants. A total of 280 healthy, term, mixed-fed infants between 60 and 120 days of age were enrolled at Shanghai. The participants were randomly assigned to one of the two study groups: the a2 infant formula group and the conventional A1/A2 infant formula group. Each group contained 140 infants. The study duration was 56 days.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Body weight measured in gram.

  Body weight measured in gram.

  Baseline, Day 14, Day 28, Day 56

Secondary Outcomes (16)

• Body length measured in centimeter.

  Baseline, Day 14, Day 28, Day 56

• Head circumference measured in centimeter.

  Baseline, Day 14, Day 28, Day 56

• Body mass index calculated from body weight and length.

  Baseline, Day 14, Day 28, Day 56

• Weight-for-age Z-score that describe the distance and direction of the weight of a participant away from the mean of the population of the same age

  Baseline, Day 14, Day 28, Day 56

• Length-for-age Z-score that describe the distance and direction of the body length of a participant away from the mean body length of the population of the same age

  Baseline, Day 14, Day 28, Day 56

Study Arms (2)

a2 Platinum Premium Infant Formula Stage 1

EXPERIMENTAL

a2 Platinum Premium Stage 1 (0-6 months) cow's milk based powder infant formula

Dietary Supplement: a2 Platinum Premium Infant Formula Stage 1

Frisolac Infant Formula Stage 1 (Dutch Edition)

ACTIVE COMPARATOR

Dutch Edition of the Frisolac Stage 1 (0-6 months) cow's milk based powder infant formula

Dietary Supplement: Frisolac Infant Formula Stage 1 (Dutch Edition)

Interventions

a2 Platinum Premium Infant Formula Stage 1 DIETARY_SUPPLEMENT

Oral intake of a2 Platinum Premium Infant Formula Stage 1 milk powder (dissolved in water)

a2 Platinum Premium Infant Formula Stage 1

Frisolac Infant Formula Stage 1 (Dutch Edition) DIETARY_SUPPLEMENT

Oral intake of Frisolac Infant Formula Step 1 (Dutch Edition) milk power (dissolved in water)

Frisolac Infant Formula Stage 1 (Dutch Edition)

Eligibility Criteria

• Age: 60 Days - 120 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy and term infants (37-42 weeks gestation);
• Birth weight between 2500g and 4500g;
• days of age after birth;
• Mixed-fed: Infants who were fed with a mixture of formula and human milk, and received daily formula consumption of more than 400ml;
• Signed informed consent obtained form the guardian(s) of the infants;
• Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey.

You may not qualify if:

• Congenital anomaly or hereditary/chronic/congenital diseases that could interfere with the study product evaluations;
• Evidence of feeding difficulties or intolerance/allergy to cow's milk;
• Conditions requiring infant feedings other than those specified in the protocol;
• Significant systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastrointestinal, or other) or parental refusal to participate;
• Acute infection or gastroenteritis at the time of enrollment;
• Participation in other clinical trials at the time of the study;
• Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.

Sponsors & Collaborators

• a2 Milk Company Ltd.: lead

Study Sites (1)

Shanghai Weierkang Pediatric Outpatient Department

Shanghai, China

Location

Related Publications (1)

• Li J, Yang T, Sheng X. Effect of Infant Formula Made With Milk Free of A1-Type beta-Casein on Growth and Comfort: A Randomized Controlled Trial. Food Sci Nutr. 2025 Jul 15;13(7):e70606. doi: 10.1002/fsn3.70606. eCollection 2025 Jul.

  PMID: 40672544 DERIVED

Study Officials

• Frank Wang

  Adjuvant Advertising (Shanghai) Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 13, 2024
• Study Start: July 14, 2023
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-01

Locations

CN (1)