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

NCT02010749 | Completed

• 1 other identifier: 9052A1-3001 PHL
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

Brief Summary

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.)

Conditions

Bottle Feeding

Outcome Measures

Primary Outcomes (1)

• Weight-for-Length Z-Scores

  Primary Efficacy Endpoint: weight-for-length Z-score based on World Health Organization (WHO) growth charts.

  2 years of age

Secondary Outcomes (6)

• Weight-for-age Z-score

  2 years of age

• Length-for-age Z-score

  2 years of age

• Head circumference-for-age Z-score

  2 years of age

• BMI-for-age Z-score

  2 years of age

• Dietary intake

  2 years of age

Other Outcomes (3)

• Stool microbiota Follow-up Study of Growth at 2 Years of Age

  2 years of age

• Stool composition

  2 years of age

• Incidence of adverse events

  2 years of age

Study Arms (2)

Control

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

Experimental

Experimental: Children who had received lower protein formula as infants

Eligibility Criteria

• Age: 2 Years - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children 2 years of age who were enrolled in the Wyeth Nutrition study

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Asian Hospital and Medical Center

Filinvest Corporate City, Alabang,, Muntinlupa City, 1780, Philippines

Location

Related Publications (1)

• 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.

  PMID: 37929831 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool

MeSH Terms

Conditions

Bottle Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: December 13, 2013
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

PH (1)