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

Not Applicable

Completed

• Conditions: Toddlers Bone Metabolism
• Interventions: Other: Experimental milk; Other: Traditional cow's milk; Other: Habitual diet

• Registration Number: NCT04799028
• Lead Sponsor: Société des Produits Nestlé (SPN)

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).

Study Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-16
• Study Start: 2021-06-19
• Primary Completion: 2022-08-16
• Study Completion: 2022-10-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New toddler milk with synbiotics and fat blend	Experimental milk	-
Traditional children's fortified cow's milk	Traditional cow's milk	-
Toddlers consuming habitual diet	Habitual diet	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Stool analyses	Day 1, Day 180	Fecal markers of gut health
Serum vitamin D	Day 1, Day 180	Measured by serum 25\[OH\]D concentration requiring 1mL of whole blood sample.
GI tolerance and stooling patterns	Day 1, Day 90, Day 180	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.
Urine and Blood bone turnover markers	Day 1, Day 180 (EXPL and CTRL groups only	serum procollagen type I N-terminal propeptide (PINP)
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.
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.
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.

Trial Locations

Locations (1)

Asian Foundation for Tropical Medicine, Inc.; 🇵🇭 Muntinlupa, Philippines