Status:
COMPLETED
Evaluation of Toddler Milk Containing L.Reuteri, Galacto-oligosaccharides and Palm-Oil Free Fat Blend
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Toddlers Bone Metabolism
Eligibility:
All Genders
2-3 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effects of experimental growing up milk (EXPL) as compared to traditional children's fortified milk (CTRL) fed for 6 months on bone mass index.
Detailed Description
A randomized, double-blind controlled clinical trial was chosen to study the effects of toddler milk containing L. reuteri and GOS (4g/L) and a low sn-1, -3 fat blend when compared to a control formul...
Eligibility Criteria
Inclusion
- All subjects must comply with all the following criteria:
- Written informed consent has been obtained from the parent(s)/legally acceptable representative (LAR).
- Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
- Child is between 24 months ±1 week to 36 months ±1 week.
- Child is not currently consuming nor has consumed any formulas or taking any supplements with pre- or probiotics at enrolment or in the past month.
- Child's parent(s)/guardian is of legal age of consent, must understand the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol.
- All subjects presenting one or more of the following criteria are excluded from participation in the study:
- Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or growth.
- History of bone, malabsorption, metabolic, congenital or chromosomal abnormality known to affect feeding or growth.
- Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment.
- Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or severe food allergies that impact diet.
- Current breast milk feeding in place of all other milk, and/or milk alternatives.
- Clinical signs of severe micronutrient deficiencies.
- Parents not willing / not able to comply with the requirements of study protocol.
- Child's participation in another interventional clinical trial.
Exclusion
Key Trial Info
Start Date :
June 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2022
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT04799028
Start Date
June 19 2021
End Date
October 28 2022
Last Update
March 24 2023
Active Locations (1)
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1
Asian Foundation for Tropical Medicine, Inc.
City of Muntinlupa, Philippines, 1781