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

This study is currently recruiting participants.
Verified September 2012 by Danone Asia Pacific Holdings Pte, Ltd.
Sponsor:
Collaborator:
Danone Research
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier:
NCT01609634
First received: May 29, 2012
Last updated: September 30, 2012
Last verified: September 2012
History of Changes
  Purpose

This study is initiated to investigate the effect of a new infant formula in healthy term Chinese 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 Chinese Subjects on Growth, Body Composition, Tolerance and Safety

Resource links provided by NLM:

U.S. FDA Resources

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: 922
Study Start Date: July 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: November 2015 (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 (10th to 90th percentile according to applicable growth charts)
  4. Chinese ethnicity, including both sets of parents and grandparents
  5. Written informed consent from parent(s)
  6. 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 have taken prebiotic supplementation during the last 2 weeks prior to date of delivery
  2. 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.
  3. Pregnant women / mothers known to suffer from hepatitis B or human immunodeficiency virus (HIV)
  4. 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

  5. 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:

  6. Infants known to have current or previous illnesses/ conditions or intervention which could interfere with the study (growth), as per investigator's clinical judgement
  7. 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
  8. Infants who need to be fed with a special diet other than a standard cow's milk-based infant formula
  9. 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)
  10. Infants with any history of or current participation in any other study involving investigational or marketed products.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609634

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

Locations
Singapore
National University of Singapore Recruiting
Singapore, Singapore, 119228
Contact: Yap Seng Chong, A/Prof, MD            
Principal Investigator: Yap Seng Chong, A/Prof, MD            
KK Women's and Children Hospital Recruiting
Singapore, Singapore, 229899
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.
Danone Research
Investigators
Principal Investigator: Yung Chiang Kenneth Kwek, A/Prof, MD KK Women's and Children Hospital
Principal Investigator: Yap Seng Chong, A/Prof, MD National University, 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: September 30, 2012
Health Authority: Singapore: National Healthcare Group

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

ClinicalTrials.gov processed this record on May 19, 2013