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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Danone Asia Pacific Holdings Pte, Ltd.
Sponsor:
Collaborator:
Nutricia Research
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier:
NCT01609634
First received: May 29, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Healthy Infants
Other: Standard infant formula/follow-on formula
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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.

Resource links provided by NLM:


Further study details as provided by Danone Asia Pacific Holdings Pte, Ltd.:

Primary Outcome Measures:
  • Weight gain per day [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    Weight gain per day from randomisation until 17 weeks of age.

  • Total weight gain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Total weight gain from birth until 12 months of age

  • Sum of skin fold thicknesses [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Recumbent length, head circumference, mid-upper arm circumference, skin folds [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Sum of four Skin-fold thickness: triceps, biceps, subscapular and suprailiac measured until 12 months of age

  • Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold measured until 24 months of age


Estimated Enrollment: 530
Study Start Date: July 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention group 1
Intervention group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
Other: Standard infant formula/follow-on formula
Standard infant formula/follow-on formula with added scGOS/lcFOS
Active Comparator: Intervention group 2
Intervention group 2: Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
Other: Standard infant formula/follow-on formula
Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
Placebo Comparator: Control group
Control group: Standard infant formula/follow-on formula with added standard fat droplets and without specific prebiotic oligosaccharides.
Other: Standard infant formula/follow-on formula
Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609634

Contacts
Contact: Jill Wong, MSc jill.wong@danone.com
Contact: Antoinette Winokan, MD antoinette.winokan@danone.com

Locations
Singapore
National University Hospital, Singapore Recruiting
Singapore, Singapore, 119228
Contact: SICS (hotline)    +65 6407 0101      
Contact: Yap Seng Chong, A/Prof, MD         
Principal Investigator: Yap Seng Chong, A/Prof, MD         
KK Women's and Children's Hospital Recruiting
Singapore, Singapore, 229899
Contact: SICS (hotline)    +65 6407 0101      
Contact: Yung Chiang Kenneth Kwek, A/Prof, MD         
Principal Investigator: Yung Chiang Kenneth Kwek, A/Prof, MD         
Sponsors and Collaborators
Danone Asia Pacific Holdings Pte, Ltd.
Nutricia Research
Investigators
Principal Investigator: Yung Chiang Kenneth Kwek, A/Prof, MD KK Women's and Children's Hospital
Principal Investigator: Yap Seng Chong, A/Prof, MD National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier: NCT01609634     History of Changes
Other Study ID Numbers: EPI.2.C/A
Study First Received: May 29, 2012
Last Updated: July 16, 2014
Health Authority: Singapore: Domain Specific Review Boards
Singapore: Central Institutional Review Board

Keywords provided by Danone Asia Pacific Holdings Pte, Ltd.:
Healthy
Term infants
Growth
Body composition

ClinicalTrials.gov processed this record on July 22, 2014