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

NCT07686224 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-08-26

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Term Infants

Interventions

OTHER

Rice formula (New formula based on hydrolysed rice proteins)

The infant is exclusively fed the infant formula based on hydrolysed rice proteins from inclusion (postnatal age: day 10 (±3)) until the postnatal age of 4 months (day 120 (±3)).

OTHER

Control formula (Standard cow's milk proteins-based formula)

The infant is exclusively fed the control formula from inclusion (postnatal age: day 10 (±3)) until the postnatal age of 4 months (day 120 (±3)).

Sponsors & Collaborators

  • Vivactis M2Research

    collaborator INDUSTRY

  • Health and Happiness Research Limited

    lead INDUSTRY

Principal Investigators

  • Sandra Brancato, MD

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
13 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-03
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07686224 on ClinicalTrials.gov