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Safety and Efficacy of Addition of Structured Lipids in Starter Formulas

NCT02332967 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2015-01-13

No results posted yet for this study

Summary

The primary objective of this trial is to demonstrate that infants receiving an infant formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the first 4 months of life, stools that are softer than those of infants receiving a control formula.

Conditions

  • Healthy Newborn Infants

Interventions

OTHER

Whey predominant starter formula

Milk powder product given to babies between 1 week and 4 months

OTHER

Whey predominant starter formula + 40% palmitic acid

Milk powder product containing 40% of palmitic acid

OTHER

Whey predominant starter formula + 50% palmitic acid

Milk powder product containing 50% of palmitic acid

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Dominique Turck, Prof · Gatroenterology and Nutrition, Pediatric dept, CHRU Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
4 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-02-29
Completion
2012-09-30

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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 NCT02332967 on ClinicalTrials.gov