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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental formula | Experimental | Young-child formula with low protein content |
|
| Control formula | Active Comparator | Young-child formula with protein content similar to that of cow's milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Young-child formula with low protein content | Dietary Supplement | Young-child formula with low protein content |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMI-for-age z-score | WHO-growth standard | Age 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI-for-age z-score | Age 72 months | |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Von Hauner Children's hospital | Munich | 80337 | Germany | |||
| Hospital Universitari Joan 23 de Tarragona. Universitat Rovira i Virgili. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41980293 | Derived | 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. | |
| 41634786 |
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| 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 |
|
| 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 |
| Body composition: air displacement plethysmography | at 24, 48 and 72 months of age |
| 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) | Age 12, 18, 24, 48 and 72 months |
| DNA methylation pattern: Methylation status of specific DNA regions (e.g. CpG sites) | Age 12, 24 and 72 months |
| Blood pressure | Age 48 and 72 months |
| Dietary intake: 24-hour recall | Age 12, 18, 24, 48 and 72 months |
| 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 | Age 12, 24 and 72 months |
| Tarragona |
| Spain |
| 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. |
| 41039386 | 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. |
| 34876419 | 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. |