Effect of Nutritional Intervention on Metabolic Response in Infants

Effect of Nutritional Intervention on Metabolic Response in Infants: A Single-Blind, Randomized, Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Glucose, High Blood; Infant Development
• Intervention / Treatment: Other: EXPL feeding regimen; Other: CTRL feeding regimen

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Las Piñas, Philippines, 1742
    • Las Piñas Doctors Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 5 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EXPL feeding regimen; Lower protein / lower estimated glycemic index regimen	Other: EXPL feeding regimen; EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)
ACTIVE_COMPARATOR: CTRL feeding regimen; Standard protein / standard glycemic index regimen	Other: CTRL feeding regimen; CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose peak	Average of the glucose peaks measured by a continuous glucose monitor	Study days 85-92

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	age 6 months, 9 months, and 12 months

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 31, 2020
• Primary Completion (ACTUAL): April 29, 2021
• Study Completion (ACTUAL): June 9, 2021

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (ACTUAL): July 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 18.17.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No