Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age

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

267 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-12-31

Brief Summary

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The primary objective of the study was to compare the growth parameters of children approximately 2\* years of age, who as infants were randomized to receive either a lower-protein formula ("experimental formula"; EF) with 12.8 g/L protein or a standard formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of life. The secondary objective was to describe diet and nutrient intake in this cohort of children. The exploratory objectives were to describe stool microbiota in a subset of this cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and minerals) in a second subset of this cohort.

(\* The mean age of subjects was 33.0 months due to a delay in the study start-up.)

Detailed Description

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This was an observational, single-site, follow-up study of healthy children who as infants who had completed study 9052A1-3000. An attempt was made to contact all subjects who had completed study 9052A1-3000 by telephone to ask them to participate in study 9052A1-3001. Approximately 66 and 60 subjects were planned to participate in the stool microbiota and stool composition substudies, respectively.

Conditions

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Bottle Feeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control

Control: Children who had received Standard formula (SF) as infants

No interventions assigned to this group

Experimental

Experimental: Children who had received lower protein formula as infants

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Children who were enrolled in the Wyeth Nutrition study are eligible to participate in this study

Exclusion Criteria

* Children who were not enrolled in the Wyeth Nutrition study are not eligible to participate in this study
* Children who have received any antibiotics and antifungal medications except topical within two weeks prior to enrollment are not eligible to participate in the stool microbiota study
* Children who are taking any medications known or suspected to affect fat digestion, absorption, and or metabolism, any vitamin and or mineral supplements which contain calcium, suppositories, bismuth-containing medications, herbal supplements, or medications that may neutralize or suppress gastric acid secretion, are not eligible to participate in the stool composition study

Minimum Eligible Age

2 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asian Hospital and Medical Center

Filinvest Corporate City, Alabang,, Muntinlupa City, Philippines

Site Status

Countries

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Philippines

References

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Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.

Reference Type DERIVED

PMID: 37929831 (View on PubMed)

Other Identifiers

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9052A1-3001 PHL

Identifier Type: -

Identifier Source: org_study_id