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

NCT ID: NCT02594683

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

359 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Key Group of Interest

Exclusively formula fed subjects since 1 month of age

No interventions assigned to this group

Other-Fed Group

Mixed feeding of formula and breast milk

No interventions assigned to this group

Breastfeeding Group

Exclusively breastfeeding at least until 4 months of age

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role collaborator

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Danone Asia Pacific Holdings Pte, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oon Hoe Teoh, MBBS

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Jian Yi Soh, MBBS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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National University Hospital, Singapore

Singapore, , Singapore

Site Status

KK Women's and Children's Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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EBB15GL04185

Identifier Type: -

Identifier Source: org_study_id