Effect of Nutritional Intervention on Metabolic Response in Infants

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483453
• Other study ID #: 18.17.INF
• Status: Completed
• Phase: N/A
• Start date: July 31, 2020
• Est. completion date: June 9, 2021

Study information

• Verified date: October 2021
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 9, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 26 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Glucose, High Blood
• Hyperglycemia
• Infant Development

Intervention

Other:
• EXPL feeding regimen
EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)
• CTRL feeding regimen
CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)

Locations

Country	Name	City	State
Philippines	Las Piñas Doctors Hospital	Las Piñas

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insulin-like growth factor-1 (IGF-1)	Urinary IGF-1	age 6 months, 9 months, and 12 months
Other	Urinary metabolomic profile	Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy.	age 6 months, 9 months, and 12 months
Primary	Glucose peak	Average of the glucose peaks measured by a continuous glucose monitor	Study days 85-92
Secondary	Glycemic response	Incremental area under the blood glucose response curve	Study days 85-92
Secondary	Glucose response variability	Mean amplitude of glycemic excursions, standard deviation, J-index	Study days 85-92
Secondary	Skinfold thickness	Subscapular and triceps skinfold thicknesses	age 6 months, 9 months, and 12 months
Secondary	Weight	Weight (g)	age 6 months, 9 months, and 12 months
Secondary	Length	Length (cm)	age 6 months, 9 months, and 12 months
Secondary	Head circumference	Head circumference (cm)	age 6 months, 9 months, and 12 months
Secondary	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
Secondary	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
Secondary	Weight-for-length z-score	Weight-for-length z-score based on WHO growth charts	age 6 months, 9 months, and 12 months
Secondary	Length-for-age z-score	Length-for-age z-score based on WHO growth charts	age 6 months, 9 months, and 12 months
Secondary	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
Secondary	BMI-for-age z-score	BMI-for-age z-score based on WHO growth charts	age 6 months, 9 months, and 12 months
Secondary	Insulin secretion	Urinary C-peptide:creatinine ratio	age 6 months, 9 months, and 12 months
Secondary	Dietary intake	Total energy, carbohydrate and protein intake calculated from food recalls / diaries	age 6 months, 9 months, and 12 months
Secondary	Stool microbiota composition	Fecal microbiota composition assessed using next generation sequencing	age 6 months, 7.5 months, 9 months, and 12 months
Secondary	Stool pH	Stool pH	age 6 months, 7.5 months, 9 months, and 12 months
Secondary	Stool microbiota metabolism	Stool organic acids	age 6 months, 7.5 months, 9 months, and 12 months
Secondary	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
Secondary	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