Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
NCT ID: NCT05868408
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
234 participants
INTERVENTIONAL
2023-08-17
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Control formula
CTRL, an infant formula with minimum protein content of 1.8g intact protein/100kcal
Control Formula
Infant formula made with intact protein - minimum 1.8g protein/100kcal
Experimental formula 1
EXPL1, an infant formula with minimum protein content of 1.9g hydrolyzed protein/100kcal
Experimental Formula 1
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Experimental formula 2
EXPL2, an infant formula identical to EXPL1 but manufactured using a different partially hydrolyzed milk protein base
Experimental Formula 2
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Interventions
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Control Formula
Infant formula made with intact protein - minimum 1.8g protein/100kcal
Experimental Formula 1
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Experimental Formula 2
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Eligibility Criteria
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Inclusion Criteria
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
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
0 Days
28 Days
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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National Guard Hospital
Jeddah, , Saudi Arabia
King Faisal Specialist Hospital and Research Center
Riyadh, , Saudi Arabia
National Guard Hospital
Riyadh, , Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Mohammed Al-Hindi
Role: primary
Other Identifiers
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21.10.INF
Identifier Type: -
Identifier Source: org_study_id