Bottle Feeding
Conditions
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.)
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.
Interventions
None listed
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight-for-Length Z-Scores | 2 years of age | Primary Efficacy Endpoint: weight-for-length Z-score based on World Health Organization (WHO) growth charts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Head circumference-for-age Z-score | 2 years of age | Head circumference-for-age Z-score based on World Health Organization (WHO) growth charts |
| BMI-for-age Z-score | 2 years of age | BMI-for-age Z-score based on WHO and Centers for Disease Control (CDC) growth charts |
| Dietary intake | 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 |
| Nutrient intake | 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) |
| Weight-for-age Z-score | 2 years of age | Weight-for-age Z-score based on World Health Organization (WHO) growth charts |
| Length-for-age Z-score | 2 years of age | Length-for-age Z-score based on World Health Organization (WHO) growth charts |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 2 years of age | Safety was evaluated from signing of the informed consent to study completion, through the recording and monitoring of adverse events. |
| Stool microbiota Follow-up Study of Growth at 2 Years of Age | 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 |
| Stool composition | 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. |
Countries
Philippines
Outcome results
None listed