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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPL feeding regimen | Experimental | Lower protein / lower estimated glycemic index regimen |
|
| CTRL feeding regimen | Active Comparator | Standard protein / standard glycemic index regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPL feeding regimen | Other | EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose peak | Average of the glucose peaks measured by a continuous glucose monitor | Study days 85-92 |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic response | Incremental area under the blood glucose response curve | Study days 85-92 |
| Glucose response variability | Mean amplitude of glycemic excursions, standard deviation, J-index |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin-like growth factor-1 (IGF-1) | Urinary IGF-1 | age 6 months, 9 months, and 12 months |
| Urinary metabolomic profile | Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy. |
Inclusion Criteria:.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Las Piñas Doctors Hospital | Las Piñas | 1742 | Philippines |
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| CTRL feeding regimen | Other | CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains) |
|
| Study days 85-92 |
| Skinfold thickness | Subscapular and triceps skinfold thicknesses | age 6 months, 9 months, and 12 months |
| Weight | Weight (g) | age 6 months, 9 months, and 12 months |
| Length | Length (cm) | age 6 months, 9 months, and 12 months |
| Head circumference | Head circumference (cm) | 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 | 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 | age 6 months, 9 months, and 12 months |
| Weight-for-length z-score | Weight-for-length z-score based on WHO growth charts | age 6 months, 9 months, and 12 months |
| Length-for-age z-score | Length-for-age z-score based on WHO growth charts | 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 | age 6 months, 9 months, and 12 months |
| BMI-for-age z-score | BMI-for-age z-score based on WHO growth charts | age 6 months, 9 months, and 12 months |
| Insulin secretion | Urinary C-peptide:creatinine ratio | age 6 months, 9 months, and 12 months |
| Dietary intake | Total energy, carbohydrate and protein intake calculated from food recalls / diaries | age 6 months, 9 months, and 12 months |
| Stool microbiota composition | Fecal microbiota composition assessed using next generation sequencing | age 6 months, 7.5 months, 9 months, and 12 months |
| Stool pH | Stool pH | age 6 months, 7.5 months, 9 months, and 12 months |
| Stool microbiota metabolism | Stool organic acids | 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. | 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. | age 6 months, 9 months, and 12 months |
| age 6 months, 9 months, and 12 months |