Overview

This trial is active, not recruiting.

Condition healthy
Treatments test product, control product 1, control product 2
Phase phase 2
Sponsor Danone Asia Pacific Holdings Pte, Ltd.
Collaborator Nutricia Research
Start date July 2012
End date August 2016
Trial size 541 participants
Trial identifier NCT01609634, EPI.2.C/A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Arm
(Active Comparator)
Subjects who started test product / control product 1 / control product 2 by 1-month of age
test product
Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
(Active Comparator)
Subjects who started test product / control product 1 / control product 2 and continued on breast-feeding
control product 1
Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
(Active Comparator)
Subjects who are exclusively breast-fed up to 4 months of age and not started on test product / control product 1 / control product 2.
control product 2
Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.

Primary Outcomes

Measure
Weight gain per day
time frame: 17 weeks
Total weight gain
time frame: 12 months
Sum of skin fold thicknesses
time frame: 24 months

Secondary Outcomes

Measure
Recumbent length, head circumference, mid-upper arm circumference, skin folds
time frame: 17 weeks
Skin-fold thickness
time frame: 12 months
Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold
time frame: 24 months

Eligibility Criteria

Male or female participants up to 28 days old.

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.

Additional Information

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.
Principal investigator Yung Chiang Kenneth Kwek, A/Prof, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Danone Asia Pacific Holdings Pte, Ltd..