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

NCT01609634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2021-10-18

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

OTHER

Test Product

Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®

OTHER

Control Product 1

Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS

OTHER

Control Product 2

Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.

Sponsors & Collaborators

  • Nutricia Research

    collaborator INDUSTRY

  • Danone Asia Pacific Holdings Pte, Ltd.

    lead INDUSTRY

Principal Investigators

  • Oon Hoe Teoh, Dr, MD · KK Women's and Children's Hospital

  • Yap Seng Chong, A/Prof, MD · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-08-31
Completion
2019-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01609634 on ClinicalTrials.gov