Evaluation of Toddler Milk Containing L.Reuteri, Galacto-oligosaccharides and Palm-Oil Free Fat Blend

Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · Mar 11, 2021

Keywords

ClinConnect Summary

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 formula. There is an additional unblinded habitual intake reference group (REF) for "real-world" comparison (including 58% non-dairy drinkers according to observational data).

Gender

ALL

Eligibility criteria

• All subjects must comply with all the following criteria:
• • 1. Written informed consent has been obtained from the parent(s)/legally acceptable representative (LAR).
• • 2. Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
• • 3. Child is between 24 months ±1 week to 36 months ±1 week.
• • 4. 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.
• • 5. 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:
• • 1. Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or growth.
• • 2. History of bone, malabsorption, metabolic, congenital or chromosomal abnormality known to affect feeding or growth.
• • 3. Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment.
• • 4. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or severe food allergies that impact diet.
• • 5. Current breast milk feeding in place of all other milk, and/or milk alternatives.
• • 6. Clinical signs of severe micronutrient deficiencies.
• • 7. Parents not willing / not able to comply with the requirements of study protocol.
• • 8. Child's participation in another interventional clinical trial.