Clinical trial NCT04483453: Effect of Nutritional Intervention on Metabolic Response in Infants
Official title: Effect of Nutritional Intervention on Metabolic Response in Infants: A Single-Blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Glucose, High Blood
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-07-23
Enrollment: 102
Sex: ALL
Minimum age (years): 24
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glucose peak
timeFrame: Study days 85-92
Secondary outcomes:
measure: Glycemic response
timeFrame: Study days 85-92
measure: Glucose response variability
timeFrame: Study days 85-92
measure: Skinfold thickness
timeFrame: age 6 months, 9 months, and 12 months
measure: Weight
timeFrame: age 6 months, 9 months, and 12 months
measure: Length
timeFrame: age 6 months, 9 months, and 12 months
measure: Head circumference
timeFrame: age 6 months, 9 months, and 12 months
measure: Body mass index (BMI)
timeFrame: age 6 months, 9 months, and 12 months
measure: Weight-for-age z-score
timeFrame: age 6 months, 9 months, and 12 months
measure: Weight-for-length z-score
timeFrame: age 6 months, 9 months, and 12 months
measure: Length-for-age z-score
timeFrame: age 6 months, 9 months, and 12 months
measure: Head circumference-for-age z-score
timeFrame: age 6 months, 9 months, and 12 months
measure: BMI-for-age z-score
timeFrame: age 6 months, 9 months, and 12 months
measure: Insulin secretion
timeFrame: age 6 months, 9 months, and 12 months
measure: Dietary intake
timeFrame: age 6 months, 9 months, and 12 months
measure: Stool microbiota composition
timeFrame: age 6 months, 7.5 months, 9 months, and 12 months
measure: Stool pH
timeFrame: age 6 months, 7.5 months, 9 months, and 12 months
measure: Stool microbiota metabolism
timeFrame: age 6 months, 7.5 months, 9 months, and 12 months
measure: Gastrointestinal (GI) tolerance
timeFrame: age 6 months, 9 months, and 12 months
measure: Health-related quality of life
timeFrame: age 6 months, 9 months, and 12 months
Other outcomes:
measure: Insulin-like growth factor-1 (IGF-1)
timeFrame: age 6 months, 9 months, and 12 months
measure: Urinary metabolomic profile
timeFrame: age 6 months, 9 months, and 12 months
Locations:
city: Las Piñas
country: Philippines
facility: Las Piñas Doctors Hospital
Study officials:
References: