Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants

Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial

This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.

Study Overview

• Status: Recruiting
• Conditions: Infant Development; Growth and Development; Infant Health; Infant Formula; Infant Nutritional Physiological Phenomena
• Intervention / Treatment: Other: Control Formula; Other: Experimental Formula 1; Other: Experimental Formula 2

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthony de Cozar; Phone Number: +41 21 785 8573; Email: anthony.decozar@rd.nestle.com

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • Recruiting
    • National Guard Hospital
    • Contact: Mohammed Al-Hindi
  • Riyadh, Saudi Arabia
    • Not yet recruiting
    • King Faisal Specialist Hospital and Research Center
    • Contact: Wajeeh Al-Dekhail
  • Riyadh, Saudi Arabia
    • Recruiting
    • National Guard Hospital
    • Contact: Mariam Al-Baqami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative [LAR]), if applicable)
2. Infant gestational age ≥37 completed weeks
3. Infant birth weight of ≥2.5 kg and ≤4.5 kg
4. Singleton birth
5. Infant postnatal age ≤28 days (date of birth = day 0)
6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
7. Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol

Exclusion Criteria:

1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
3. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
4. Infants with special dietary needs other than standard infant formula
5. Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet
6. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
7. Currently participating or having participated in another interventional clinical trial prior to enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control formula; CTRL, an infant formula with minimum protein content of 1.8g intact protein/100kcal	Other: Control Formula; Infant formula made with intact protein - minimum 1.8g protein/100kcal
Experimental: Experimental formula 1; EXPL1, an infant formula with minimum protein content of 1.9g hydrolyzed protein/100kcal	Other: Experimental Formula 1; Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Experimental: Experimental formula 2; EXPL2, an infant formula identical to EXPL1 but manufactured using a different partially hydrolyzed milk protein base	Other: Experimental Formula 2; Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in growth in first 4 months of life between control and experimental groups	To demonstrate that growth from enrollment to age 4 months of infants fed experimental formula 1 (EXPL1) or experimental formula 2 (EXPL2) is non-inferior to that of infants fed control formula (CTRL). This is measured by weight gain velocity (g/day).	From enrollment to age 4 months
Equivalence in growth in first 4 months of life in experimental groups	To demonstrate that growth from enrollment to age 4 months is equivalent between infants fed EXPL1 or EXPL2. This is measured by weight gain velocity (g/day).	From enrollment to age 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Enrollment and age 4, 6, and 12 months
Stooling pattern	Stool frequency and consistency assessed using a 3-day infant stool diary.	Age 2 and 4 months
Atopic dermatitis severity	Atopic dermatitis severity assessed using the Patient Oriented Eczema Measure (POEM). POEM scores range from 0 to 28, with lower scores indicating lower atopic dermatitis severity.	Enrollment and age 4, 6, and 12 months
Allergy-related symptoms	Allergy-related symptoms assessed using the Multi-Organ System Questionnaire for Infants (MOSQ-I). MOSQ-I scores range from 0 to 105, with lower scores indicating lower allergy-related symptom burden.	Enrollment and age 4, 6, and 12 months
Dietary intake	Total energy and macronutrient intake calculated from food recalls / diaries	Age 6 months
Weight	Weight (g)	Enrollment and age 1, 2, 3, 4, and 6 months
Length	Length (cm)	Enrollment and age 1, 2, 3, 4, and 6 months
Head circumference	Head circumference (cm)	Enrollment and age 1, 2, 3, 4, and 6 months
Weight-for-age z-score	Weight-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.	Enrollment and age 1, 2, 3, 4, and 6 months
Weight-for-length z-score	Weight-for-length z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.	Enrollment and age 1, 2, 3, 4, and 6 months
Length-for-age z-score	Length-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.	Enrollment and age 1, 2, 3, 4, and 6 months
Head circumference-for-age z-score	Head circumference-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.	Enrollment and age 1, 2, 3, 4, and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool microbiota composition	Stool microbiota composition assessed using shotgun metagenomic analysis	Age 4 months
Stool microbiota metabolism	Stool organic acids and other metabolites	Age 4 months
Fecal peptides	Fecal milk-derived peptides	Age 4 months
Urinary metabolomic profile	Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy	Age 4 months

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21.10.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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