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

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ClinicalTrials.gov Identifier: NCT02010749
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
Nestlé

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.)


Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 267 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age
Study Start Date : October 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Weight-for-Length Z-Scores [ Time Frame: 2 years of age ]
    Primary Efficacy Endpoint: weight-for-length Z-score based on World Health Organization (WHO) growth charts.


Secondary Outcome Measures :
  1. Weight-for-age Z-score [ Time Frame: 2 years of age ]
    Weight-for-age Z-score based on World Health Organization (WHO) growth charts

  2. Length-for-age Z-score [ Time Frame: 2 years of age ]
    Length-for-age Z-score based on World Health Organization (WHO) growth charts

  3. Head circumference-for-age Z-score [ Time Frame: 2 years of age ]
    Head circumference-for-age Z-score based on World Health Organization (WHO) growth charts

  4. BMI-for-age Z-score [ Time Frame: 2 years of age ]
    BMI-for-age Z-score based on WHO and Centers for Disease Control (CDC) growth charts

  5. Dietary intake [ Time Frame: 2 years of age ]

    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

  6. Nutrient intake [ Time Frame: 2 years of age ]

    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)


Other Outcome Measures:
  1. Stool microbiota Follow-up Study of Growth at 2 Years of Age [ Time Frame: 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. Stool composition [ Time Frame: 2 years of age ]

    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.

  3. Incidence of adverse events [ Time Frame: 2 years of age ]
    Safety was evaluated from signing of the informed consent to study completion, through the recording and monitoring of adverse events.


Biospecimen Retention:   Samples Without DNA
stool


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Ages Eligible for Study:   2 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children 2 years of age who were enrolled in the Wyeth Nutrition study
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010749


Locations
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Philippines
Asian Hospital and Medical Center
Filinvest Corporate City, Alabang,, Muntinlupa City, Philippines, 1780
Sponsors and Collaborators
Nestlé

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02010749     History of Changes
Other Study ID Numbers: 9052A1-3001 PHL
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013