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Completed

NCT Number: NCT02010749

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.)

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Key information

Conditions

Bottle Feeding Behavior Feeding Behavior

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asian Hospital and Medical Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 13, 2013
Registry last updated
Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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