HealthyNCT06256094
The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants
A study testing a2 Platinum Premium Infant Formula Stage 1 and Frisolac Infant Formula Stage 1 (Dutch Edition) in people with Healthy, run by a2 Milk Company Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 120 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- a2 Platinum Premium Infant Formula Stage 1 and Frisolac Infant Formula Stage 1 (Dutch Edition)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2023to 3 Nov 2023
- 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 60 to 120 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy and term infants (37-42 weeks gestation);
- Birth weight between 2500g and 4500g;
- 60-120 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Primary objective:
To compare the growth measurements of the infants fed with the a2 infant formula with those fed with conventional A1/A2 infant formula during the study period.
Secondary objectives:
To compare the two study groups in
- Dermatitis quality of life
- Formula tolerability and acceptability
- All medically confirmed adverse events
The study included four visits at day 0 (baseline), day 14, day 28 and day 56. Information of efficacy outcomes were collected at each visit. Subject diary was used to record tolerance data and daily formula feeding amount during the study. The parents of the participants were also required evaluate their satisfaction with the study formula at the last visit.
- Conditions
- Healthy
- Being tested
- a2 Platinum Premium Infant Formula Stage 1, Frisolac Infant Formula Stage 1 (Dutch Edition)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a2 Platinum Premium Infant Formula Stage 1Dietary supplement
Oral intake of a2 Platinum Premium Infant Formula Stage 1 milk powder (dissolved in water)
Frisolac Infant Formula Stage 1 (Dutch Edition)Dietary supplement
Oral intake of Frisolac Infant Formula Step 1 (Dutch Edition) milk power (dissolved in water)
| Study group | Role | What they receive |
|---|---|---|
| a2 Platinum Premium Infant Formula Stage 1 | Experimental | a2 Platinum Premium Stage 1 (0-6 months) cow's milk based powder infant formula Receives: 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 Receives: Dietary Supplement: Frisolac Infant Formula Stage 1 (Dutch Edition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight measured in gram.
Body weight measured in gram.
Measured: Baseline, Day 14, Day 28, Day 56
Secondary outcomes (16)
Body length measured in centimeter.
Body length measured in centimeter.
Measured: Baseline, Day 14, Day 28, Day 56
Head circumference measured in centimeter.
Head circumference measured in centimeter.
Measured: Baseline, Day 14, Day 28, Day 56
Body mass index calculated from body weight and length.
Body mass index calculated from as weight (kg) dived by the square of body length (meter).
Measured: 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
A standard score for measuring weight growth calculated according to the WHO Growth Standards. The weight-for-age Z-score is the distance and direction of the weight of a participant away from the mean body weight of the population of the same age.
Measured: 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
A standard score for measuring body length growth calculated according to the WHO Growth Standards. The length-for-age Z-score is the distance and direction of the body length of a participant away from the mean body length of the population of the same age.
Measured: Baseline, Day 14, Day 28, Day 56
BMI-for-age Z-score that describe the distance and direction of the body mass index of a participant away from the mean body mass index of the population of the same age
A standard score for measuring body mass index (BMI) calculated according to the WHO Growth Standards. The BMI-for-age Z-score is the distance and direction of the body mass index of a participant away from the mean body mass index of the population of the same age.
Measured: Baseline, Day 14, Day 28, Day 56
Head circumference-for-age Z-score that describe the distance and direction of the head circumference of a participant away from the mean head circumference of the population of the same age
A standard score for measuring head circumference calculated according to the WHO Growth Standards. The head circumference-for-age Z-score is the distance and direction of the head circumference of a participant away from the mean head circumference of the population of the same age.
Measured: Baseline, Day 14, Day 28, Day 56
Weight-for-length Z-score that describe the distance and direction of the weight of a participant away from the mean weight of the population of the same body length
A standard score for measuring weight-for-length growth calculated according to the WHO Growth Standards. The weight-for-length Z-score is the distance and direction of the body weight of a participant away from the mean body weight of the population of the same body length.
Measured: Baseline, Day 14, Day 28, Day 56
Infants' gastrointestinal symptom score evaluated using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)
The IGSQ score is the sum of 5 domains scores of stooling, spitting up/vomiting, crying, fussiness and flatulence, derived by summing up the relating raw individual scores. Each raw score range from 0 to 5, with higher score indicating more severe gastrointestinal symptoms. Data was collected daily, and the average score during the past week of each visit was used for analyses.
Measured: Baseline, Day 14, Day 28, Day 56
Number of crying periods evaluated in each 15-minutes period during a day
Number of 15-minute periods at morning, afternoon, evening and night, and the daily total number of crying periods. Data was collected daily, and the average daily number of crying periods during the past week of each visit was used for analyses.
Measured: Baseline, Day 14, Day 28, Day 56
Infants' Dermatitis Quality of Life Index (IDQoL) that measured participants' quality of life related to dermatitis
An index to evaluate the quality of life related to dermatitis during the past week of each visit. The IDQoL index is the sum of one score for evaluating dermatitis severity (range from 0 to 4 indicating increasing severity from no symptom to very servere symptom) and 10 individual scores (each range from 0 to 3 indicating increasing frequency from none to very often) evaluating the possible problems encountered in daily life due to dermatitis, including itching and scratching, mood, time to get to sleep, sleep disturbance, disturbed playing or swimming, disturbed family activities, problems during meal times, problems from treatment, problems at dressing, and problems at bath time.
Measured: Baseline, Day 14, Day 28, Day 56
Average daily formula intake amount (ml/day) during the past week measured by formula intake diary
Daily formula intake amount was recorded in ml. The average daily formula intake amount during the past week of each visit was used to assess formula feeding amount.
Measured: Baseline, Day 14, Day 28, Day 56
Percent of participants with relieved gastrointestinal symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire
Parents were required to report whether the gastrointestinal symptoms of the participant have been relieved by the end of the study. Dichotomized variable with 2 levels: Yes or No.
Measured: Day 56
Percent of participants with relieved skin symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire
Parents were required to report whether participant's skin symptoms such as eczema or dermatitis have been relieved by the end of the study. Dichotomized variable with 2 levels: Yes or No.
Measured: Day 56
Percent of parents of the participants with intention of continuing to feed the child with the study formula, measured in 3 levels: Yes, No, or Not sure using the Formula Satisfaction Questionnaire
Parents were required to indicate their intention of continuing to feed the child with the study formula. Categorical variable with 3 levels: Yes, No, or Not sure.
Measured: Day 56
Percent of overall satisfaction levels with the study formula, measured in 4 levels: Satisfied, Neutral, Dissatisfied, or Not sure using the Formula Satisfaction Questionnaire
Overall satisfaction with study formula was evaluated by the parents at the end of the study. Category variable with 4 levels: Satisfied, Neutral, Dissatisfied, or Not sure.
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start14 Jul 2023
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- a2 Milk Company Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Wang, Study director, Adjuvant Advertising (Shanghai) Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256094
- Sponsor's protocol ID
- A2220616005
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40672544
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT06256094
- Acronym / sponsor ID
- A2220616005
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- a2 Milk Company Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 13 Feb 2024 (actual)
- 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 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.
Detailed description
Primary objective:
To compare the growth measurements of the infants fed with the a2 infant formula with those fed with conventional A1/A2 infant formula during the study period.
Secondary objectives:
To compare the two study groups in
- Dermatitis quality of life
- Formula tolerability and acceptability
- All medically confirmed adverse events
The study included four visits at day 0 (baseline), day 14, day 28 and day 56. Information of efficacy outcomes were collected at each visit. Subject diary was used to record tolerance data and daily formula feeding amount during the study. The parents of the participants were also required evaluate their satisfaction with the study formula at the last visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a2 Platinum Premium Infant Formula Stage 1 | Experimental | Dietary Supplement: a2 Platinum Premium Infant Formula Stage 1a2 Platinum Premium Stage 1 (0-6 months) cow's milk based powder infant formula |
| Frisolac Infant Formula Stage 1 (Dutch Edition) | Active comparator | Dietary Supplement: Frisolac Infant Formula Stage 1 (Dutch Edition)Dutch Edition of the Frisolac Stage 1 (0-6 months) cow's milk based powder infant formula |
Who may qualify
- Ages
- 60 to 120 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy and term infants (37-42 weeks gestation);
- Birth weight between 2500g and 4500g;
- 60-120 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;
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| a2 Platinum Premium Infant Formula Stage 1Oral intake of a2 Platinum Premium Infant Formula Stage 1 milk powder (dissolved in water) | Dietary supplement | a2 Platinum Premium Infant Formula Stage 1 |
| Frisolac Infant Formula Stage 1 (Dutch Edition)Oral intake of Frisolac Infant Formula Step 1 (Dutch Edition) milk power (dissolved in water) | Dietary supplement | Frisolac Infant Formula Stage 1 (Dutch Edition) |
Primary outcome
Body weight measured in gram.
Time frame: Baseline, Day 14, Day 28, Day 56
Body weight measured in gram.
16 secondary outcomes
Body length measured in centimeter.
Time frame: Baseline, Day 14, Day 28, Day 56
Head circumference measured in centimeter.
Time frame: Baseline, Day 14, Day 28, Day 56
Body mass index calculated from body weight and length.
Time frame: 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
Time frame: 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
Time frame: Baseline, Day 14, Day 28, Day 56
BMI-for-age Z-score that describe the distance and direction of the body mass index of a participant away from the mean body mass index of the population of the same age
Time frame: Baseline, Day 14, Day 28, Day 56
Head circumference-for-age Z-score that describe the distance and direction of the head circumference of a participant away from the mean head circumference of the population of the same age
Time frame: Baseline, Day 14, Day 28, Day 56
Weight-for-length Z-score that describe the distance and direction of the weight of a participant away from the mean weight of the population of the same body length
Time frame: Baseline, Day 14, Day 28, Day 56
Infants' gastrointestinal symptom score evaluated using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)
Time frame: Baseline, Day 14, Day 28, Day 56
Number of crying periods evaluated in each 15-minutes period during a day
Time frame: Baseline, Day 14, Day 28, Day 56
Infants' Dermatitis Quality of Life Index (IDQoL) that measured participants' quality of life related to dermatitis
Time frame: Baseline, Day 14, Day 28, Day 56
Average daily formula intake amount (ml/day) during the past week measured by formula intake diary
Time frame: Baseline, Day 14, Day 28, Day 56
Percent of participants with relieved gastrointestinal symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire
Time frame: Day 56
Percent of participants with relieved skin symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire
Time frame: Day 56
Percent of parents of the participants with intention of continuing to feed the child with the study formula, measured in 3 levels: Yes, No, or Not sure using the Formula Satisfaction Questionnaire
Time frame: Day 56
Percent of overall satisfaction levels with the study formula, measured in 4 levels: Satisfied, Neutral, Dissatisfied, or Not sure using the Formula Satisfaction Questionnaire
Time frame: Day 56
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 13 Feb 2024.
- Derived from this study: PubMed 40672544Li 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.
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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.
Frank Wang study director
Adjuvant Advertising (Shanghai) Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a2 Platinum Premium Infant Formula Stage 1 and Frisolac Infant Formula Stage 1 (Dutch Edition) in people with Healthy, run by a2 Milk Company Ltd. at 1 site 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 7 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Body weight measured in gram. (time frame: Baseline, Day 14, Day 28, Day 56). 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 NCT06256094, which also lists 1 linked publication.
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 13 Feb 2024.