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

March 22, 2023 updated by: Société des Produits Nestlé (SPN)

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
273

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Speed of sound (SOS)
Time Frame: Day 1, Day 90, Day 180
Speed of sound (SOS) using a quantitative ultrasound methods measured by Pediatric Sunlight 9000 device
Day 1, Day 90, Day 180

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GI tolerance and stooling patterns
Time Frame: Day 1
Stool patterns including stool frequency will be recorded retrospectively via 24-hour GI Symptom and Behavior Recall
Day 1
GI tolerance and stooling patterns
Time Frame: Day 1
Stool patterns including stool consistency will be recorded retrospectively via 24-hour GI Symptom and Behavior Recall
Day 1
GI tolerance and stooling patterns
Time Frame: Day 90, Day 180
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
Time Frame: Day 90, Day 180
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
Time Frame: Day 1, Day 90, Day 180
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
Time Frame: 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.
Day 1, Day 90, Day 180
Stool analyses
Time Frame: Day 1, Day 180
Excretion of fecal calcium fatty acid soaps
Day 1, Day 180
Stool analyses
Time Frame: Day 1, Day 180
Measurement of stool calcium content
Day 1, Day 180
Serum vitamin D
Time Frame: Day 1, Day 180
Measured by serum 25[OH]D concentration requiring 1mL of whole blood sample.
Day 1, Day 180
Urine and Blood bone turnover markers
Time Frame: Day 1, Day 180 (EXPL and CTRL groups only)
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
Time Frame: Day 1, Day 180 (EXPL and CTRL groups only
serum procollagen type I N-terminal propeptide (PINP)
Day 1, Day 180 (EXPL and CTRL groups only
Gut microbiota
Time Frame: Day 1, Day 180
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
Time Frame: Day 1, Day 180
Determination of fecal short chain fatty acids (SCFAs)
Day 1, Day 180
Stool analyses
Time Frame: Day 1, Day 180
Fecal pH and metabolism.
Day 1, Day 180
Stool analyses
Time Frame: Day 1, Day 180
Fecal markers of gut health
Day 1, Day 180
Physical strength
Time Frame: 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.
Day 1, Day 180
Vitamin B
Time Frame: Day 1, Day 180
serum vitamin B concentration requiring 2 mL of whole blood sample.
Day 1, Day 180
Dietary intake patterns
Time Frame: 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.
Day 1, Day 180
Child quality of life using validated ITQOL SF-47 questionnaire
Time Frame: Day 1, Day 180
assessed using the parent-reported questionnaires
Day 1, Day 180
Outdoor Playtime
Time Frame: Day 1 and Day 180
Assessed using parent-reported questionnaire on Outdoor Playtime recording number of hours child spent outside.
Day 1 and Day 180
Child temperament
Time Frame: 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.
Day 1, Day 180

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anthropometry
Time Frame: Day 1, Day 180
Measurement of weight
Day 1, Day 180
Anthropometry
Time Frame: Day 1, Day 180
Measurement of height
Day 1, Day 180
Anthropometry
Time Frame: Day 1, Day 180
Measurement of head circumference
Day 1, Day 180
Safety endpoints
Time Frame: Day 1, Day 180 and follow up of 14 days after last intake of study products
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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