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

Bottle Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010749
• Other study ID #: 9052A1-3001 PHL
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: December 9, 2013
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Observational

Clinical Trial 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.)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 3 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bottle Feeding

Locations

Country	Name	City	State
Philippines	Asian Hospital and Medical Center	Filinvest Corporate City, Alabang,	Muntinlupa City

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Primary	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	No
Secondary	Weight-for-age Z-score	Weight-for-age Z-score based on World Health Organization (WHO) growth charts	2 years of age	No
Secondary	Length-for-age Z-score	Length-for-age Z-score based on World Health Organization (WHO) growth charts	2 years of age	No
Secondary	Head circumference-for-age Z-score	Head circumference-for-age Z-score based on World Health Organization (WHO) growth charts	2 years of age	No
Secondary	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	No
Secondary	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	No
Secondary	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	No