NCT04799028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 19, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

March 11, 2021

Last Update Submit

March 22, 2023

Conditions

Toddlers Bone Metabolism

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (21)

  • GI tolerance and stooling patterns

    Day 1

  • GI tolerance and stooling patterns

    Day 1

  • GI tolerance and stooling patterns

    Day 90, Day 180

  • GI tolerance and stooling patterns

    Day 90, Day 180

  • GI tolerance and stooling patterns

    Day 1, Day 90, Day 180

  • +16 more secondary outcomes

Other Outcomes (4)

  • Anthropometry

    Day 1, Day 180

  • Anthropometry

    Day 1, Day 180

  • Anthropometry

    Day 1, Day 180

  • +1 more other outcomes

Study Arms (3)

Traditional children's fortified cow's milk

ACTIVE COMPARATOR
Other: Traditional cow's milk

New toddler milk with synbiotics and fat blend

EXPERIMENTAL
Other: Experimental milk

Toddlers consuming habitual diet

OTHER
Other: Habitual diet

Interventions

Traditional cow's milkOTHER

Fortified cow's milk

Traditional children's fortified cow's milk
Experimental milkOTHER

Milk with synbiotics and fat blend

New toddler milk with synbiotics and fat blend
Habitual dietOTHER

Habitual diet

Toddlers consuming habitual diet

Eligibility Criteria

Age2 Years - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Asian Foundation for Tropical Medicine, Inc.

City of Muntinlupa, 1781, Philippines

Location

Related Publications (1)

  • 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.

    PMID: 41387706DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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).
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 16, 2021

Study Start

June 19, 2021

Primary Completion

August 16, 2022

Study Completion

October 28, 2022

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

PH(1)