The purpose of this study is to determine the glucose response of complementary feeding regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs).
This is a prospective, randomized, single-blind, controlled, 2-arm parallel group trial in infants aged 6 months (26 weeks) at enrollment, who are no longer breastfed, and who are ready but have not yet started complementary feeding. They will be fed one of two different isocaloric feeding regimens (Experimental \[EXPL\] or Control \[CTRL\]) consisting of different follow-up formulas (FUFs) and infant cereals (ICs). The main purpose of this study is to determine the glucose response of these two different complementary feeding regimens. All enrolled infants will participate in the trial for approximately 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
102
EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)
CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)
Las Piñas Doctors Hospital
Las Piñas, Philippines
Glucose peak
Average of the glucose peaks measured by a continuous glucose monitor
Time frame: Study days 85-92
Glycemic response
Incremental area under the blood glucose response curve
Time frame: Study days 85-92
Glucose response variability
Mean amplitude of glycemic excursions, standard deviation, J-index
Time frame: Study days 85-92
Skinfold thickness
Subscapular and triceps skinfold thicknesses
Time frame: age 6 months, 9 months, and 12 months
Weight
Weight (g)
Time frame: age 6 months, 9 months, and 12 months
Length
Length (cm)
Time frame: age 6 months, 9 months, and 12 months
Head circumference
Head circumference (cm)
Time frame: age 6 months, 9 months, and 12 months
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m\^2
Time frame: age 6 months, 9 months, and 12 months
Weight-for-age z-score
Weight-for-age z-score based on World Health Organization (WHO) growth charts
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Time frame: age 6 months, 9 months, and 12 months
Weight-for-length z-score
Weight-for-length z-score based on WHO growth charts
Time frame: age 6 months, 9 months, and 12 months
Length-for-age z-score
Length-for-age z-score based on WHO growth charts
Time frame: age 6 months, 9 months, and 12 months
Head circumference-for-age z-score
Head circumference-for-age z-score based on WHO growth charts
Time frame: age 6 months, 9 months, and 12 months
BMI-for-age z-score
BMI-for-age z-score based on WHO growth charts
Time frame: age 6 months, 9 months, and 12 months
Insulin secretion
Urinary C-peptide:creatinine ratio
Time frame: age 6 months, 9 months, and 12 months
Dietary intake
Total energy, carbohydrate and protein intake calculated from food recalls / diaries
Time frame: age 6 months, 9 months, and 12 months
Stool microbiota composition
Fecal microbiota composition assessed using next generation sequencing
Time frame: age 6 months, 7.5 months, 9 months, and 12 months
Stool pH
Stool pH
Time frame: age 6 months, 7.5 months, 9 months, and 12 months
Stool microbiota metabolism
Stool organic acids
Time frame: age 6 months, 7.5 months, 9 months, and 12 months
Gastrointestinal (GI) tolerance
GI tolerance assessed using the Infant Gastrointestinal Symptom Questionnaire (IGSQ). IGSQ scores range from 13 to 65, with lower scores indicating lower GI symptom burden.
Time frame: age 6 months, 9 months, and 12 months
Health-related quality of life
Health-related quality of life using the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47). ITQOL-SF47 scores range from 0 to 100, with higher scores indicating a more favorable health-related quality of life.
Time frame: age 6 months, 9 months, and 12 months