Effect of Nutritional Intervention on Metabolic Response in Infants
- Conditions
- Infant DevelopmentGlucose, High Blood
- Interventions
- Other: EXPL feeding regimenOther: CTRL feeding regimen
- Registration Number
- NCT04483453
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
.
- Written informed consent has been obtained from both parent / liable parent or legally acceptable representative (LAR), if applicable
- 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
- Infant is no longer breastfeeding or receiving breast milk, has not yet started FUF, and is developmentally ready to begin complementary feeding
- 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.
- At screening visit (visit 0), infant is 24 - 26 weeks (5½ - 6 months) old
- Weight-for-height value >-2 standard deviations from the WHO Child Growth Standards median
- 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
- Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
- Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, gluten sensitivity or severe food allergies that impact diet
- Born to mothers with gestational diabetes or type 1 diabetes
- Major medical/surgical event requiring prolonged hospitalization during the first 6 months
- 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
- 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
- Currently participating or having participated in another clinical trial within 4 weeks prior to trial start
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EXPL feeding regimen EXPL feeding regimen Lower protein / lower estimated glycemic index regimen CTRL feeding regimen CTRL feeding regimen Standard protein / standard glycemic index regimen
- Primary Outcome Measures
Name Time Method Glucose peak Study days 85-92 Average of the glucose peaks measured by a continuous glucose monitor
- Secondary Outcome Measures
Name Time Method 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
Weight-for-length z-score age 6 months, 9 months, and 12 months Weight-for-length 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
Stool microbiota composition age 6 months, 7.5 months, 9 months, and 12 months Fecal microbiota composition assessed using next generation sequencing
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
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
Stool microbiota metabolism age 6 months, 7.5 months, 9 months, and 12 months Stool organic acids
Glucose response variability Study days 85-92 Mean amplitude of glycemic excursions, standard deviation, J-index
Weight age 6 months, 9 months, and 12 months Weight (g)
Length-for-age z-score age 6 months, 9 months, and 12 months Length-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
Length age 6 months, 9 months, and 12 months Length (cm)
Stool pH age 6 months, 7.5 months, 9 months, and 12 months Stool pH
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.
Glycemic response Study days 85-92 Incremental area under the blood glucose response curve
Skinfold thickness age 6 months, 9 months, and 12 months Subscapular and triceps skinfold thicknesses
Head circumference age 6 months, 9 months, and 12 months Head circumference (cm)
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.
Trial Locations
- Locations (1)
Las Piñas Doctors Hospital
🇵🇭Las Piñas, Philippines