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

Danone

Status: Completed

Conditions: Healthy

Treatments: Other: Control Product 1; Other: Control Product 2; Other: Test Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT01609634

EBB15GL04184

Details and patient eligibility

About

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

Full 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.

Enrollment: 541 patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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541 participants in 3 patient groups

Key Group of interest

Active Comparator group

Description:

Subjects who started test product / control product 1 / control product 2 by 1-month of age

Treatment:

Other: Test Product

Other-fed Group

Active Comparator group

Description:

Subjects who started test product / control product 1 / control product 2 and continued on breast-feeding

Treatment:

Other: Control Product 1

Breast Fed Reference Group

Active Comparator group

Description:

Subjects who are exclusively breast-fed up to 4 months of age and not started on test product / control product 1 / control product 2.

Treatment:

Other: Control Product 2