Health TrialsbyHealthPanel

Growth and Health Efficacy of Novel Infant Formula : A Randomized Trial

ConditionInfant Growth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorBiostime (Changsha) Nutrition Foods Limited

About this trial

Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy full-term infants (gestational age 37-42 weeks).

Age 12-18 months (inclusive).

Weight below the 75th percentile according to the "Growth Reference Standards for Chinese Children Under 7 Years Old".

Has started or plans to start stage 3 formula feeding before enrollment.

Disqualifiers

Known allergy to milk protein or the study formula.

Known allergic constitution or high allergy risk (parent with allergic constitution).

Malnutrition assessed by investigator.

Chronic infectious disease, metabolic disease, genetic disease, or any other condition affecting feeding or growth and development.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Investigational Formula 1

    Dietary supplement

    The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals

  • Investigational Formula 2

    Dietary supplement

    The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Investigational Formula 1Experimental treatment 1 intervention
Group B: Investigational Formula 2Experimental treatment 1 intervention
Group C: Control: Commercial Infant Formula or Dairy ProductsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Height

Measured in centimeters (cm)

Time frame
Baseline (Day -7) to Day 90
2

Change in Weight

Measured in kilograms (kg)

Time frame
Baseline (Day -7) to Day 90
3

Comprehensive Nutritional Development Assessment

(1) Annual growth rate (cm/year); (2) MUAC to head circumference ratio; (3) Weight-for-age Z-score (WAZ); (4) Length-for-age Z-score (LAZ); (5) Weight-for-length Z-score (WLZ); (6) BMI-for-age Z-score (BAZ).

Time frame
Baseline (Day -7) to Day 90

Secondary outcomes

1

Change in Salivary sIgA

Saliva sample collected in microliters (µL)

Time frame
Baseline (Day -7) to Day 90
2

Change in Salivary Lysozyme

Saliva sample collected in microliters (µL)

Time frame
Baseline (Day -7) to Day 90
3

Change in Fecal sIgA

Stool sample collected

Time frame
Baseline (Day -7) to Day 90
4

Change in Fecal Calprotectin

Stool sample collected

Time frame
Baseline (Day -7) to Day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biostime (Changsha) Nutrition Foods Limited

Lead sponsor

Shenzhen University

Collaborator

Source ClinicalTrials.gov
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