Status:
COMPLETED
Effect of Nutritional Intervention on Metabolic Response in Infants
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Infant Development
Glucose, High Blood
Eligibility:
All Genders
24-26 years
Phase:
NA
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 y...
Eligibility Criteria
Inclusion
- .
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2021
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04483453
Start Date
July 31 2020
End Date
June 9 2021
Last Update
October 5 2021
Active Locations (1)
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1
Las Piñas Doctors Hospital
Las Piñas, Philippines, 1742