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HealthyNCT02907502

Toddler Milk Intervention Trial

A study testing Young-child formula with low protein content and Young-child formula with protein content similar to that of cow's milk in people with Healthy, run by Société des Produits Nestlé (SPN) at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 11 to 13 monthsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Young-child formula with low protein content and Young-child formula with protein content similar to that of cow's milk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,618 participants
Where
2 sitesin 2 countries
Study dates
Sep 2016to Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 13 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • Dr Von Hauner Children's hospital

    Munich, 80337

Other trials in Germany

Spain1 site

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

    Tarragona

Other trials in Spain

About this study

Official title: Effects of Milk Protein Intake in Young Children on Early Growth and Later Obesity Risk: a Multicentre Randomized Clinical Trial

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

Read the detailed description

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
Healthy
Being tested
Young-child formula with low protein content, Young-child formula with protein content similar to that of cow's milk

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Young-child formula with low protein contentDietary supplement

    Young-child formula with low protein content

  • Young-child formula with protein content similar to that of cow's milkDietary supplement

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

Study groups in NCT02907502
Study groupRoleWhat they receive
Experimental formulaExperimentalYoung-child formula with low protein content
Receives: Dietary Supplement: Young-child formula with low protein content
Control formulaActive comparatorYoung-child formula with protein content similar to that of cow's milk
Receives: Dietary Supplement: Young-child formula with protein content similar to that of cow's milk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI-for-age z-score

    WHO-growth standard

    Measured: Age 24 months

Secondary outcomes (11)

  1. BMI-for-age z-score

    Measured: Age 72 months

  2. The percentage of overweight and obese children

    CDC definition: Overweight above 85th to less than the 95th percentile and obese 95th percentile or greater and analyzed by the method of Peacock (Dichotomising continuous data while retaining statistical power using a distributional approach, Statistics in medicine, 2012).

    Measured: Age 24 months

  3. The percentage of overweight and obese children

    Measured: Age 72 months

  4. 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

    Measured: Age 12, 18, 24, 48 and 72 months

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

    Measured: Age 24 and 48 months

  6. Body composition: air displacement plethysmography

    Measured: at 24, 48 and 72 months of age

  7. Metabolomic profile: Plasma and urine metabolic indicators of energy and protein metabolism (metabolomics with a focus on carnitines, amino acid catabolism, ketone bodies, Krebs cycle, and bacterial utilization of protein and carbohydrates)

    Measured: Age 12, 18, 24, 48 and 72 months

  8. DNA methylation pattern: Methylation status of specific DNA regions (e.g. CpG sites)

    Measured: Age 12, 24 and 72 months

  9. Blood pressure

    Measured: Age 48 and 72 months

  10. Dietary intake: 24-hour recall

    Measured: Age 12, 18, 24, 48 and 72 months

  11. Metabolic and endocrine markers: Blood and Urine markers

    Blood: Complete blood count, Glucose, Creatinine, Ferritin (measured only at 24 months), 25-OH vitamin D (measured only at 24 months), Triglycerides, Total cholesterol, HDL- and LDL-cholesterol, Insulin, FGF-21, IGF-1, IGF-BP2, IGF-BP3, Leptin, Adiponectin, Ghrelin, Amino Acids, Serum albumin, Urea, C-reactive protein, Osteocalcin / Urine: Calcium, C-peptide, Creatinine, Urea nitrogen

    Measured: Age 12, 24 and 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJul 2021
  4. Study completionOct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,618 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907502
Sponsor's protocol ID
13.29.INF
Status last verified
Dec 2024
First submitted
31 Aug 2016
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Grote V, Demmelmair H, Luque V, Escribano J, Parada E, Grathwohl D, Geyer F, Koletzko B; ToMI trial group. The toddler milk intervention trial (ToMI): A randomized controlled trial on the effect of protein content in young child formula on BMI and growth. Clin Nutr. 2026 Jun;61:106648. doi: 10.1016/j.clnu.2026.106648. Epub 2026 Mar 30.

    PubMed 41980293

  • 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;25(1):68. doi: 10.1186/s12944-026-02872-y.

    PubMed 41634786

  • 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.

    PubMed 41039386

  • 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.

    PubMed 34876419

Questions about this trial

What is this clinical trial studying?

A study testing Young-child formula with low protein content and Young-child formula with protein content similar to that of cow's milk in people with Healthy, run by Société des Produits Nestlé (SPN) at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI-for-age z-score (time frame: Age 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907502, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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Toddler Milk Intervention Trial (NCT02907502) | AzTrials