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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-19

Study Completion Date

2022-10-28

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Toddlers Bone Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The study is a double-blinded study. The identity of specific product will be masked to subjects, support staff, investigators and sponsor's personnel except the manufacture and quality unit at Nestle (production factory).

Study Groups

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Traditional children's fortified cow's milk

Group Type ACTIVE_COMPARATOR

Traditional cow's milk

Intervention Type OTHER

Fortified cow's milk

New toddler milk with synbiotics and fat blend

Group Type EXPERIMENTAL

Experimental milk

Intervention Type OTHER

Milk with synbiotics and fat blend

Toddlers consuming habitual diet

Group Type OTHER

Habitual diet

Intervention Type OTHER

Habitual diet

Interventions

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Traditional cow's milk

Fortified cow's milk

Intervention Type OTHER

Experimental milk

Milk with synbiotics and fat blend

Intervention Type OTHER

Habitual diet

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes