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

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.)

Study Overview

• Status: Completed
• Conditions: Bottle Feeding

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 267

Contacts and Locations

Study Locations

• Philippines
  • Muntinlupa City
    • Filinvest Corporate City, Alabang,, Muntinlupa City, Philippines, 1780
      • Asian Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Control: Children who had received Standard formula (SF) as infants
Experimental; Experimental: Children who had received lower protein formula as infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight-for-age Z-score	Weight-for-age Z-score based on World Health Organization (WHO) growth charts	2 years of age
Length-for-age Z-score	Length-for-age Z-score based on World Health Organization (WHO) growth charts	2 years of age
Head circumference-for-age Z-score	Head circumference-for-age Z-score based on World Health Organization (WHO) growth charts	2 years of age
BMI-for-age Z-score	BMI-for-age Z-score based on WHO and Centers for Disease Control (CDC) growth charts	2 years of age
Dietary intake	Dietary intake (servings per day), percent contribution to energy intake, and percent contribution to protein intake of Dietary endpoints included mean intake (servings per day), percentage contribution to energy intake, and percentage contribution to protein intake of: Cereal/cereal products; Starchy roots/tubers; Sugars/syrups; Fats/oils; Fish/meat/poultry; Eggs; Milk and milk products; Dried beans/nuts/seeds; Vegetables; Fruits; Miscellaneous foods	2 years of age
Nutrient intake	Nutrition endpoints included mean intake and percentage adequacy based on the recommended intake of: Total energy (kcal); Protein (g); Carbohydrates (g) (mean intake only); Fat (g) (mean intake only); Iron (mg); Retinol equivalents (μg); Calcium (g); Thiamin (mg); Riboflavin (mg); Niacin (mg); Ascorbic acid (mg); Iodine (μg); Vitamin D (μg); Zinc (μg)	2 years of age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool microbiota Follow-up Study of Growth at 2 Years of Age	Stool microbiota included relative abundance of the following classes of bacteria, expressed as a percentage of total bacteria: Bifidobacteria; Bacteroides; Clostridia; Enterobacteriaceae; Lactobacilli; Streptococci	2 years of age
Stool composition	quantitative measures of the following parameters in stool wet and dry weight: Total soap fatty acids (%); Individual soap fatty acids (C12:0, C14:0, C16:0, C18:0, C18:1, C18:2) (mg/g); Nonsoap fatty acids (%); Total fatty acids (%); Total lipids (%); Soap lipids (%); Nonsoap lipids (%); Minerals: calcium (%), magnesium (%), and phosphorus (%); Nitrogen (%) In addition, stool solids and stool moisture were assessed as percentage of stool wet weight only.	2 years of age
Incidence of adverse events	Safety was evaluated from signing of the informed consent to study completion, through the recording and monitoring of adverse events.	2 years of age

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 9052A1-3001 PHL