Glucose, High Blood, Infant Development
Conditions
Brief summary
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).
Detailed description
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.
Interventions
OTHEREXPL feeding regimen
EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)
OTHERCTRL feeding regimen
CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 26 Weeks
Healthy volunteers
Yes
Inclusion criteria
. 1. Written informed consent has been obtained from both parent / liable parent or legally acceptable representative (LAR), if applicable 2. Healthy infant who was singleton, full-term gestational birth (≥ 37 completed weeks of gestation) with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg 3. Infant is no longer breastfeeding or receiving breast milk, has not yet started FUF, and is developmentally ready to begin complementary feeding 4. Infant's parent(s)/guardian is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol. 5. At screening visit (visit 0), infant is 24 - 26 weeks (5½ - 6 months) old 6. Weight-for-height value \>-2 standard deviations from the WHO Child Growth Standards median
Exclusion criteria
1. Chronic infectious, metabolic, or other disease including any condition that in the opinion of the investigator may impact feeding, growth or adherence to study procedures 2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis) 3. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, gluten sensitivity or severe food allergies that impact diet 4. Born to mothers with gestational diabetes or type 1 diabetes 5. Major medical/surgical event requiring prolonged hospitalization during the first 6 months 6. Receiving or having received insulin, growth hormone or any other medication known to affect glucose or carbohydrate metabolism or pre- or probiotics known to affect fecal microbiota prior to enrollment 7. Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol 8. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose peak | Study days 85-92 | Average of the glucose peaks measured by a continuous glucose monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic response | Study days 85-92 | Incremental area under the blood glucose response curve |
| Glucose response variability | Study days 85-92 | Mean amplitude of glycemic excursions, standard deviation, J-index |
| Skinfold thickness | age 6 months, 9 months, and 12 months | Subscapular and triceps skinfold thicknesses |
| Weight | age 6 months, 9 months, and 12 months | Weight (g) |
| Length | age 6 months, 9 months, and 12 months | Length (cm) |
| Head circumference | age 6 months, 9 months, and 12 months | Head circumference (cm) |
| Stool pH | age 6 months, 7.5 months, 9 months, and 12 months | Stool pH |
| Stool microbiota metabolism | age 6 months, 7.5 months, 9 months, and 12 months | Stool organic acids |
| Body mass index (BMI) | age 6 months, 9 months, and 12 months | Weight and height will be combined to report BMI in kg/m\^2 |
| Weight-for-age z-score | age 6 months, 9 months, and 12 months | Weight-for-age z-score based on World Health Organization (WHO) growth charts |
| Stool microbiota composition | age 6 months, 7.5 months, 9 months, and 12 months | Fecal microbiota composition assessed using next generation sequencing |
| Health-related quality of life | age 6 months, 9 months, and 12 months | 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. |
| Gastrointestinal (GI) tolerance | age 6 months, 9 months, and 12 months | 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. |
| Weight-for-length z-score | age 6 months, 9 months, and 12 months | Weight-for-length z-score based on WHO growth charts |
| Length-for-age z-score | age 6 months, 9 months, and 12 months | Length-for-age z-score based on WHO growth charts |
| Head circumference-for-age z-score | age 6 months, 9 months, and 12 months | Head circumference-for-age z-score based on WHO growth charts |
| BMI-for-age z-score | age 6 months, 9 months, and 12 months | BMI-for-age z-score based on WHO growth charts |
| Insulin secretion | age 6 months, 9 months, and 12 months | Urinary C-peptide:creatinine ratio |
| Dietary intake | age 6 months, 9 months, and 12 months | Total energy, carbohydrate and protein intake calculated from food recalls / diaries |
Other
| Measure | Time frame | Description |
|---|---|---|
| Insulin-like growth factor-1 (IGF-1) | age 6 months, 9 months, and 12 months | Urinary IGF-1 |
| Urinary metabolomic profile | age 6 months, 9 months, and 12 months | Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy. |
Countries
Philippines
Outcome results
None listed