New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Test Product; Other: Control Product 1; Other: Control Product 2

• Registration Number: NCT01609634
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

Brief Summary

This study is initiated to investigate the effect of a new infant formula in healthy term subjects on growth, body composition, tolerance and safety.

Detailed Description

This is a "best after breast design" to measure the effect of this new infant formula in healthy term subjects on growth, body composition, tolerance and safety including immune status, gut microbiota, and early indicators (markers) of disease. These markers will be explored if they could predict the risk of eczema and other allergic disease, and to evaluate if these markers are influenced by early nutrition.

Study Timeline

• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-01
• Study Start: 2012-07
• Primary Completion: 2016-08
• Study Completion: 2019-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 541

Inclusion Criteria

1. Healthy term infants (gestational age ≥ 37 and ≤ 42 weeks)
2. Age ≤ 28 days
3. Birth weight within normal range for gestational age and sex (3rd to 90th percentile according to applicable growth charts)
4. Head circumference at birth within normal range (3rd to 90th percentile of the chart)
5. Chinese, Malay, or Indian ethnicity
6. Written informed consent from parent(s)
7. Currently reside in Singapore and with the intention to reside in Singapore for at least the next 2 years

Exclusion criteria for the pregnant women/parents:

1. Pregnant women / mothers who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation.

2. Pregnant women / mothers known to suffer from hepatitis B or human immunodeficiency virus (HIV)

3. Pregnant women / mothers known to have other significant medical condition (including during pregnancy) that might interfere with the study or known to affect intra-uterine growth (including, but not limited to: placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication), as per investigator's clinical judgement

4. Incapability of the parents to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements

   Exclusion criteria for the subjects:

5. Infants known to have current or previous illnesses/ conditions or intervention which could interfere with the study (growth), as per investigator's clinical judgement

6. Infants with known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement

7. Infants who need to be fed with a special diet other than a standard cow's milk-based infant formula

8. Infants who received any other infant formula, except the infant formula given in between birth and the initial breast-feeding (maximum of 3 consecutive days)

9. Infants with any history of or current participation in any other study involving investigational or marketed products.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Key Group of interest	Test Product	Subjects who started test product / control product 1 / control product 2 by 1-month of age
Other-fed Group	Control Product 1	Subjects who started test product / control product 1 / control product 2 and continued on breast-feeding
Breast Fed Reference Group	Control Product 2	Subjects who are exclusively breast-fed up to 4 months of age and not started on test product / control product 1 / control product 2.

Primary Outcome Measures

Name	Time	Method
Weight gain per day	17 weeks	Weight gain per day from randomisation until 17 weeks of age.
Sum of skin fold thicknesses	24 months	Sum of skin fold thicknesses: triceps, biceps, suprailiac, subscapular until 24 months of age in subjects receiving the test product 1, test product 2, or control product.
Total weight gain	12 months	Total weight gain from birth until 12 months of age

Secondary Outcome Measures

Name	Time	Method
Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold	24 months	Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold measured until 24 months of age
Recumbent length, head circumference, mid-upper arm circumference, skin folds	17 weeks	Recumbent length, head circumference, mid-upper arm circumference, skin folds gain per day for subjects receiving test product 1 or test product 2
Skin-fold thickness	12 months	Sum of four Skin-fold thickness: triceps, biceps, subscapular and suprailiac measured until 12 months of age

Trial Locations

Locations (2)

National University Hospital, Singapore; 🇸🇬 Singapore, Singapore

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore