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Toddler Milk Intervention Trial

NCT ID: NCT02907502

Last Updated: 2024-12-06

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

1618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2024-10-31

Brief Summary

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To assess growth of children (enrolled between 11.5 and 13.5 months) fed with two iso-energetic, young-child formulas with different protein content during the second year of life

Detailed Description

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This study is designed to investigate in a randomized double-blind parallel-group trial the growth and metabolic effects of different contributions of protein to total energy intakes in healthy children during the second year of life

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental formula

Young-child formula with low protein content

Group Type EXPERIMENTAL

Young-child formula with low protein content

Intervention Type DIETARY_SUPPLEMENT

Young-child formula with low protein content

Control formula

Young-child formula with protein content similar to that of cow's milk

Group Type ACTIVE_COMPARATOR

Young-child formula with protein content similar to that of cow's milk

Intervention Type DIETARY_SUPPLEMENT

Young-child formula with protein content similar to that of cow's milk

Interventions

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Young-child formula with low protein content

Young-child formula with low protein content

Intervention Type DIETARY_SUPPLEMENT

Young-child formula with protein content similar to that of cow's milk

Young-child formula with protein content similar to that of cow's milk

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Having obtained his/her parents' (or his/her legally accepted representative \[LAR's\] written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parents/LAR have been informed of all pertinent aspects of the study
* Child was born full term (≥ 37 weeks of gestation)
* Age at enrollment: between 11.5 months and 13.5 months of age
* 2.5 kg ≤ birth weight ≤ 4.5 kg
* Born from a singleton pregnancy
* Child's parent(s)/LAR is of legal age of consent, has sufficient local language skills to complete the informed consent and other study documents, is able to be contacted directly by telephone throughout the study, and is willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria

* Diagnosed disorder considered to interfere with nutrition or growth (e.g. malabsorptive disorders as short bowel syndrome, inflammatory bowel disease; neurological and congenital disorders that may delay growth as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity: Prader willi syndrome, Angelman syndrome, etc.)
* Cows' milk allergy
* Lactose intolerance
* Participation in any other interventional clinical trial during the 4 weeks prior to enrollment
* Infant who is being breastfed at the time of enrollment
* Infant who does not usually drink 300ml of cow's and/or formula milk per day
* Institutionalized children
* Child or child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
Minimum Eligible Age

11 Months

Maximum Eligible Age

13 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr Von Hauner Children's hospital

Munich, , Germany

Site Status

Hospital Universitari Joan 23 de Tarragona. Universitat Rovira i Virgili.

Tarragona, , Spain

Site Status

Countries

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Germany Spain

References

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Ferry JM, Escribano J, Gispert-LLaurado M, Koletzko B, Grote V. Impact of cut-point methods on classification of physical activity and sedentary behaviour of toddlers. BMC Public Health. 2025 Oct 2;25(1):3290. doi: 10.1186/s12889-025-24636-6.

Reference Type DERIVED
PMID: 41039386 (View on PubMed)

Grote V, Jaeger V, Escribano J, Zaragoza M, Gispert M, Grathwohl D, Koletzko B. Effect of milk protein content in Toddler formula on later BMI and obesity risk: protocol of the multicentre randomised controlled Toddler Milk Intervention (ToMI) trial. BMJ Open. 2021 Dec 7;11(12):e048290. doi: 10.1136/bmjopen-2020-048290.

Reference Type DERIVED
PMID: 34876419 (View on PubMed)

Other Identifiers

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13.29.INF

Identifier Type: -

Identifier Source: org_study_id