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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Enrollment
- 541
- Locations
- 2
- Primary Endpoint
- Weight gain per day
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy term infants (gestational age ≥ 37 and ≤ 42 weeks)
- •Age ≤ 28 days
- •Birth weight within normal range for gestational age and sex (3rd to 90th percentile according to applicable growth charts)
- •Head circumference at birth within normal range (3rd to 90th percentile of the chart)
- •Chinese, Malay, or Indian ethnicity
- •Written informed consent from parent(s)
- •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:
- •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.
- •Pregnant women / mothers known to suffer from hepatitis B or human immunodeficiency virus (HIV)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Weight gain per day
Time Frame: 17 weeks
Weight gain per day from randomisation until 17 weeks of age.
Sum of skin fold thicknesses
Time Frame: 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
Time Frame: 12 months
Total weight gain from birth until 12 months of age
Secondary Outcomes
- Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold(24 months)
- Recumbent length, head circumference, mid-upper arm circumference, skin folds(17 weeks)
- Skin-fold thickness(12 months)