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

Healthy Clinical Trial

— Venus  

Official title:

A Randomised, Controlled, Double-blind Trial to Investigate the Effects of a New Infant Formula in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609634
• Other study ID #: EBB15GL04184
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: December 2019

Study information

• Verified date: October 2021
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: December 2019
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Test Product
Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
• Control Product 1
Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
• Control Product 2
Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	National University Hospital, Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.	Nutricia Research

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain per day	Weight gain per day from randomisation until 17 weeks of age.	17 weeks
Primary	Total weight gain	Total weight gain from birth until 12 months of age	12 months
Primary	Sum of skin fold thicknesses	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.	24 months
Secondary	Recumbent length, head circumference, mid-upper arm circumference, skin folds	Recumbent length, head circumference, mid-upper arm circumference, skin folds gain per day for subjects receiving test product 1 or test product 2	17 weeks
Secondary	Skin-fold thickness	Sum of four Skin-fold thickness: triceps, biceps, subscapular and suprailiac measured until 12 months of age	12 months
Secondary	Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold	Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold measured until 24 months of age	24 months