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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional children's fortified cow's milk | Active Comparator |
| |
| New toddler milk with synbiotics and fat blend | Experimental |
| |
| Toddlers consuming habitual diet | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional cow's milk | Other | Fortified cow's milk |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Speed of sound (SOS) | Speed of sound (SOS) using a quantitative ultrasound methods measured by Pediatric Sunlight 9000 device | Day 1, Day 90, Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| GI tolerance and stooling patterns | Stool patterns including stool frequency will be recorded retrospectively via 24-hour GI Symptom and Behavior Recall | Day 1 |
| GI tolerance and stooling patterns |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometry | Measurement of weight | Day 1, Day 180 |
| Anthropometry | Measurement of height | Day 1, Day 180 |
All subjects must comply with all the following criteria:
All subjects presenting one or more of the following criteria are excluded from participation in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Foundation for Tropical Medicine, Inc. | City of Muntinlupa | 1781 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41387706 | Derived | Bonnet N, Capeding MR, Siegwald L, Garcia-Garcera M, Desgeorges T, Tytgat HLP, Krattinger LF, Lebumfacil J, Phee LC, Moll JM, Gudjonsson A, Rodriguez-Garcia P, Baruchet M, Feige JN, Jankovic I, Chen Y, Egli D, Horcajada MN. A young child formula with Limosilactobacillus reuteri and GOS modulates gut microbiome and enhances bone and muscle development: a randomized trial. Nat Commun. 2025 Dec 12;17(1):237. doi: 10.1038/s41467-025-66930-2. |
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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).
| Experimental milk |
| Other |
Milk with synbiotics and fat blend |
|
| Habitual diet | Other | Habitual diet |
|
Stool patterns including stool consistency will be recorded retrospectively via 24-hour GI Symptom and Behavior Recall
| Day 1 |
| GI tolerance and stooling patterns | Stool patterns including stool frequency will be recorded using 3-day GI Symptom and Behavior diary | Day 90, Day 180 |
| GI tolerance and stooling patterns | Stool patterns including stool consistency will be recorded using 3-day GI Symptom and Behavior diary | Day 90, Day 180 |
| GI tolerance and stooling patterns | Parent perceptions of GI symptoms using parent-reported questionnaire Toddler Gut Comfort Questionnaire (GCQ) using VAS from 1-Never to 6-Always with higher scores indicating increasing GI burden. | Day 1, Day 90, Day 180 |
| GI tolerance and stooling patterns | Parent perceptions of GI-related behaviors using parent-reported questionnaire Toddler Gut Comfort Questionnaire (GCQ) using VAS from 1-Never to 6-Always with higher scores indicating increasing GI burden. | Day 1, Day 90, Day 180 |
| Stool analyses | Excretion of fecal calcium fatty acid soaps | Day 1, Day 180 |
| Stool analyses | Measurement of stool calcium content | Day 1, Day 180 |
| Serum vitamin D | Measured by serum 25[OH]D concentration requiring 1mL of whole blood sample. | Day 1, Day 180 |
| Urine and Blood bone turnover markers | Bone accretion markers in urinary [C-terminal cross-linked telopeptides of type I collagen (CTX)](streamdown:incomplete-link) | Day 1, Day 180 (EXPL and CTRL groups only) |
| Urine and Blood bone turnover markers | serum procollagen type I N-terminal propeptide (PINP) | Day 1, Day 180 (EXPL and CTRL groups only |
| Gut microbiota | Gut microbiota analyzed for microbiome composition and diversity using next generation shotgun metagenomics sequencing, requiring 3g of stool sample. | Day 1, Day 180 |
| Stool analyses | Determination of fecal short chain fatty acids (SCFAs) | Day 1, Day 180 |
| Stool analyses | Fecal pH and metabolism. | Day 1, Day 180 |
| Stool analyses | Fecal markers of gut health | Day 1, Day 180 |
| Physical strength | Hand grip test (Jamar hand dynamometer) tailored for toddlers will be used as previously described Bohannon et al Pediatric Physical Therapy 2017. | Day 1, Day 180 |
| Vitamin B | serum vitamin B concentration requiring 2 mL of whole blood sample. | Day 1, Day 180 |
| Dietary intake patterns | Intake patterns are assessed using parent-reported questionnaire Child Eating Behavior Questionnaire including variety of food groups consumed as well as behaviors rated from Never to Always. | Day 1, Day 180 |
| Child quality of life using validated ITQOL SF-47 questionnaire | assessed using the parent-reported questionnaires | Day 1, Day 180 |
| Outdoor Playtime | Assessed using parent-reported questionnaire on Outdoor Playtime recording number of hours child spent outside. | Day 1 and Day 180 |
| Child temperament | Children's Behavior Questionnaire (very short form), consisting of 36 questions and 3 scales on child temperament domains Surgency, Negative Affect and Effort Control with each question ranging 1-extremely untrue to 7- extremely true of parent observing various behaviors. | Day 1, Day 180 |
| Anthropometry | Measurement of head circumference | Day 1, Day 180 |
| Safety endpoints | Standard AEs reporting for safety assessment | Day 1, Day 180 and follow up of 14 days after last intake of study products |