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

Société des Produits Nestlé (SPN)273 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

273

Conditions

Toddlers Bone Metabolism

Interventions

Traditional cow's milkOTHER

Fortified cow's milk

Experimental milkOTHER

Milk with synbiotics and fat blend

Habitual dietOTHER

Habitual diet

Eligibility

Sex: ALLMin age: 2 YearsMax age: 3 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Asian Foundation for Tropical Medicine, Inc.

City of Muntinlupa, Philippines

Outcomes

Primary Outcomes

Speed of sound (SOS)

Speed of sound (SOS) using a quantitative ultrasound methods measured by Pediatric Sunlight 9000 device

Time frame: Day 1, Day 90, Day 180