Toddlers Bone Metabolism
Conditions
Brief summary
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.
Detailed description
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).
Interventions
OTHERTraditional cow's milk
Fortified cow's milk
OTHERExperimental milk
Milk with synbiotics and fat blend
OTHERHabitual diet
Habitual diet
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
2 Years to 3 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects must comply with all the following criteria: 1. Written informed consent has been obtained from the parent(s)/legally acceptable representative (LAR). 2. Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg. 3. Child is between 24 months ±1 week to 36 months ±1 week. 4. Child is not currently consuming nor has consumed any formulas or taking any supplements with pre- or probiotics at enrolment or in the past month. 5. Child's parent(s)/guardian is of legal age of consent, must understand the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol. All subjects presenting one or more of the following criteria are excluded from participation in the study: 1. Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or growth. 2. History of bone, malabsorption, metabolic, congenital or chromosomal abnormality known to affect feeding or growth. 3. Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment. 4. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or severe food allergies that impact diet. 5. Current breast milk feeding in place of all other milk, and/or milk alternatives. 6. Clinical signs of severe micronutrient deficiencies. 7. Parents not willing / not able to comply with the requirements of study protocol. 8. Child's participation in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speed of sound (SOS) | Day 1, Day 90, Day 180 | Speed of sound (SOS) using a quantitative ultrasound methods measured by Pediatric Sunlight 9000 device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child temperament | Day 1, Day 180 | 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. |
| Child quality of life using validated ITQOL SF-47 questionnaire | Day 1, Day 180 | assessed using the parent-reported questionnaires |
| Outdoor Playtime | Day 1 and Day 180 | Assessed using parent-reported questionnaire on Outdoor Playtime recording number of hours child spent outside. |
| GI tolerance and stooling patterns | Day 1 | Stool patterns including stool frequency will be recorded retrospectively via 24-hour GI Symptom and Behavior Recall |
| Stool analyses | Day 1, Day 180 | Excretion of fecal calcium fatty acid soaps |
| Serum vitamin D | Day 1, Day 180 | Measured by serum 25\[OH\]D concentration requiring 1mL of whole blood sample. |
| Urine and Blood bone turnover markers | Day 1, Day 180 (EXPL and CTRL groups only) | Bone accretion markers in urinary \[C-terminal cross-linked telopeptides of type I collagen (CTX) |
| Gut microbiota | Day 1, Day 180 | Gut microbiota analyzed for microbiome composition and diversity using next generation shotgun metagenomics sequencing, requiring 3g of stool sample. |
| Physical strength | Day 1, Day 180 | Hand grip test (Jamar hand dynamometer) tailored for toddlers will be used as previously described Bohannon et al Pediatric Physical Therapy 2017. |
| Vitamin B | Day 1, Day 180 | serum vitamin B concentration requiring 2 mL of whole blood sample. |
| Dietary intake patterns | Day 1, Day 180 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoints | Day 1, Day 180 and follow up of 14 days after last intake of study products | Standard AEs reporting for safety assessment |
| Anthropometry | Day 1, Day 180 | Measurement of weight |
Countries
Philippines
Outcome results
None listed