Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula

Starting soon · Not applicable

Conditions studied: Healthy Term Infants

In brief

The goal of this interventional clinical trial is to compare the growth parameters of healthy term infants fed either a new experimental rice hydrolyzed rice protein-based formula or a control formula (standard cow's milk protein-based formula), from their study enrollment until the age of 4 months (postnatal age of 120 days). The main question it aims to answer is whether daily weight gain of infants fed the experimental formula during the first 4 months of life is non-inferior to that of infants fed the control formula. Participants are fed exclusively with their assigned formula from enrollment until 120 days of postnatal age. Parents record any deviation from exclusive feeding with the assigned formula (e.g., intake of solid foods, unauthorized beverages, or any other infant formula). During the 3 days prior to each study visit (on postnatal days 20, 30, 60, 90, and 120): * They record all baby bottles consumed by their children * They assess their child's digestive tolerance of the formula, behavioral parameters, and acceptance of the formula. They evaluate their child's quality of life at enrollment, and on postnatal days 60 and 120.

Key facts

Study ID

NCT07686224

Run by

Health and Happiness Research Limited

People needed

156

Starts

2026-06-01

Expected to finish

2028-02-01

Last updated by the study team

2026-07-07

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

Full record on ClinicalTrials.gov

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