AzTrials
AzTrials

Toddlers Bone MetabolismNCT04799028

Evaluation of Toddler Milk Containing L.Reuteri, Galacto-oligosaccharides and Palm-Oil Free Fat Blend

A study testing Traditional cow's milk, Experimental milk and Habitual diet in people with Toddlers Bone Metabolism, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 3 yearsHealthy volunteers can take part
Conditions the study is for
Toddlers Bone Metabolism
What is being tested?
Traditional cow's milk, Experimental milk and Habitual diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
1 sitePhilippines
Study dates
19 Jun 2021to 28 Oct 2022
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 2 to 3 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • Asian Foundation for Tropical Medicine, Inc.

    City of Muntinlupa, 1781

Other trials in Philippines

About this study

Official title: Evaluation of Toddler Milk Containing L.Reuteri, Galacto-oligosaccharides and Palm-Oil Free Fat Blend On Bone Metabolism Among Healthy Toddlers

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.

Read the 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).

Being tested
Traditional cow's milk, Experimental milk, Habitual diet

What participants receive

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

  • Traditional cow's milkOther

    Fortified cow's milk

  • Experimental milkOther

    Milk with synbiotics and fat blend

  • Habitual dietOther

    Habitual diet

Study groups in NCT04799028
Study groupRoleWhat they receive
Traditional children's fortified cow's milkActive comparatorNot described
Receives: Other: Traditional cow's milk
New toddler milk with synbiotics and fat blendExperimentalNot described
Receives: Other: Experimental milk
Toddlers consuming habitual dietOtherNot described
Receives: Other: Habitual diet

What is being measured

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

  1. Speed of sound (SOS)

    Speed of sound (SOS) using a quantitative ultrasound methods measured by Pediatric Sunlight 9000 device

    Measured: Day 1, Day 90, Day 180

Secondary outcomes (21)

  1. GI tolerance and stooling patterns

    Stool patterns including stool frequency will be recorded retrospectively via 24-hour GI Symptom and Behavior Recall

    Measured: Day 1

  2. GI tolerance and stooling patterns

    Stool patterns including stool consistency will be recorded retrospectively via 24-hour GI Symptom and Behavior Recall

    Measured: Day 1

  3. GI tolerance and stooling patterns

    Stool patterns including stool frequency will be recorded using 3-day GI Symptom and Behavior diary

    Measured: Day 90, Day 180

  4. GI tolerance and stooling patterns

    Stool patterns including stool consistency will be recorded using 3-day GI Symptom and Behavior diary

    Measured: Day 90, Day 180

  5. 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.

    Measured: Day 1, Day 90, Day 180

  6. 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.

    Measured: Day 1, Day 90, Day 180

  7. Stool analyses

    Excretion of fecal calcium fatty acid soaps

    Measured: Day 1, Day 180

  8. Stool analyses

    Measurement of stool calcium content

    Measured: Day 1, Day 180

  9. Serum vitamin D

    Measured by serum 25[OH]D concentration requiring 1mL of whole blood sample.

    Measured: Day 1, Day 180

  10. Urine and Blood bone turnover markers

    Bone accretion markers in urinary [C-terminal cross-linked telopeptides of type I collagen (CTX)

    Measured: Day 1, Day 180 (EXPL and CTRL groups only)

  11. Urine and Blood bone turnover markers

    serum procollagen type I N-terminal propeptide (PINP)

    Measured: Day 1, Day 180 (EXPL and CTRL groups only

  12. Gut microbiota

    Gut microbiota analyzed for microbiome composition and diversity using next generation shotgun metagenomics sequencing, requiring 3g of stool sample.

    Measured: Day 1, Day 180

  13. Stool analyses

    Determination of fecal short chain fatty acids (SCFAs)

    Measured: Day 1, Day 180

  14. Stool analyses

    Fecal pH and metabolism.

    Measured: Day 1, Day 180

  15. Stool analyses

    Fecal markers of gut health

    Measured: Day 1, Day 180

  16. Physical strength

    Hand grip test (Jamar hand dynamometer) tailored for toddlers will be used as previously described Bohannon et al Pediatric Physical Therapy 2017.

    Measured: Day 1, Day 180

  17. Vitamin B

    serum vitamin B concentration requiring 2 mL of whole blood sample.

    Measured: Day 1, Day 180

  18. 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.

    Measured: Day 1, Day 180

  19. Child quality of life using validated ITQOL SF-47 questionnaire

    assessed using the parent-reported questionnaires

    Measured: Day 1, Day 180

  20. Outdoor Playtime

    Assessed using parent-reported questionnaire on Outdoor Playtime recording number of hours child spent outside.

    Measured: Day 1 and Day 180

  21. 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.

    Measured: Day 1, Day 180

Timeline

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

  1. First posted16 Mar 2021
  2. Study start19 Jun 2021
  3. Primary completion16 Aug 2022
  4. Study completion28 Oct 2022

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04799028
Sponsor's protocol ID
20.10.INF
Status last verified
Mar 2023
First submitted
11 Mar 2021
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 41387706

Questions about this trial

What is this clinical trial studying?

A study testing Traditional cow's milk, Experimental milk and Habitual diet in people with Toddlers Bone Metabolism, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.

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

Who may be eligible to take part?

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 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. 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?

Speed of sound (SOS) (time frame: Day 1, Day 90, Day 180). 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 NCT04799028, which also lists 1 linked publication.

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 24 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in