Toddler Milk Intervention Trial

NCT02907502 | Completed

• 1 other identifier: 13.29.INF
• Study Type: interventional
• Target: 1,618
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• BMI-for-age z-score

  WHO-growth standard

  Age 24 months

Secondary Outcomes (11)

• BMI-for-age z-score

  Age 72 months

• The percentage of overweight and obese children

  Age 24 months

• The percentage of overweight and obese children

  Age 72 months

• Growth parameters: Anthropometry: Weight, Length, Heel knee length, Mid-arm circumference, Waist circumference, Hip circumference (only 48 months and 72 months), Head circumference, Triceps skinfold, Subscapular skinfold

  Age 12, 18, 24, 48 and 72 months

• Child's development: Parental rating of child development with Ages & Stages Questionnaires®

  Age 24 and 48 months

Study Arms (2)

Experimental formula

EXPERIMENTAL

Young-child formula with low protein content

Dietary Supplement: Young-child formula with low protein content

Control formula

ACTIVE COMPARATOR

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

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

Interventions

Young-child formula with low protein content DIETARY_SUPPLEMENT

Young-child formula with low protein content

Experimental formula

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

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

Control formula

Eligibility Criteria

• Age: 11 Months - 13 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (2)

Dr Von Hauner Children's hospital

Munich, 80337, Germany

Location

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

Tarragona, Spain

Location

Related Publications (3)

• Neiss J, Demmelmair H, Geyer F, Triebswetter A, Angkasa D, Escribano J, Ferre N, Gispert-Llaurado M, Koletzko B, Bechtold-Dalla Pozza S, Grote V. Associations of insulin-like growth factor 1 and IGF binding proteins 2 and 3 with lipids in toddlers. Lipids Health Dis. 2026 Feb 3. doi: 10.1186/s12944-026-02872-y. Online ahead of print.

  PMID: 41634786 DERIVED

• 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.

  PMID: 41039386 DERIVED

• 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.

  PMID: 34876419 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2021
• Study Completion: October 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); DE (1)