A Follow-up Study to Investigate the Effects of a New Infant Formula on Growth and Body Composition (VenusFU)

Danone

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02594683

EBB15GL04185

Details and patient eligibility

About

A follow-up study of a randomised, controlled, study to investigate the effects of a new infant formula given in the first 12 months of life on growth and body composition up to 5 years of age

Full description

A follow-up study of a randomised, controlled, study to investigate the effects of a new infant formula given in the first 12 months of life on growth and body composition up to 5 years of age. Participants from Venus study will be invited to participate in this follow-up study.

Hypothesis: Significant difference in body mass index (BMI) development for subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the control product scGOS/lcFOS and standard formula. No significant difference in growth of subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the breast-feeding reference group.

Enrollment: 359 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participation in the intervention period of VENUS study until 12 months of age or participation in the VENUS study as breast-fed reference group
• Written informed consent from parent(s) or legally acceptable representatives

Exclusion criteria

• Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements

Trial design

359 participants in 3 patient groups

Key Group of Interest

Description:

Exclusively formula fed subjects since 1 month of age

Other-Fed Group

Description:

Mixed feeding of formula and breast milk

Breastfeeding Group

Description:

Exclusively breastfeeding at least until 4 months of age