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

Nestlé

Status: Completed

Conditions: Toddlers Bone Metabolism

Treatments: Other: Habitual diet; Other: Experimental milk; Other: Traditional cow's milk

Study type: Interventional

Funder types: Industry

Identifiers

NCT04799028

20.10.INF

Details and patient eligibility

About

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.

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

Enrollment: 273 patients

Sex: All

Ages: 2 to 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

273 participants in 3 patient groups

Traditional children's fortified cow's milk

Active Comparator group

Treatment:

Other: Traditional cow's milk

New toddler milk with synbiotics and fat blend

Experimental group

Treatment:

Other: Experimental milk

Toddlers consuming habitual diet

Other group

Treatment:

Other: Habitual diet