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

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.

Study Overview

• Status: Completed
• Conditions: Toddlers Bone Metabolism
• Intervention / Treatment: Other: Traditional cow's milk; Other: Experimental milk; Other: Habitual diet

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 Type: Interventional
• Enrollment (Actual): 273
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Muntinlupa, Philippines, 1781
    • Asian Foundation for Tropical Medicine, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional children's fortified cow's milk	Other: Traditional cow's milk; Fortified cow's milk
Experimental: New toddler milk with synbiotics and fat blend	Other: Experimental milk; Milk with synbiotics and fat blend
Other: Toddlers consuming habitual diet	Other: Habitual diet; Habitual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometry	Measurement of weight	Day 1, Day 180
Anthropometry	Measurement of height	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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2021
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20.10.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No