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Completed

NCT Number: NCT04799028

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

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.

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Key information

Conditions

Toddlers Bone Metabolism

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Foundation for Tropical Medicine, Inc.

City of Muntinlupa, 1781, Philippines

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

All subjects must comply with all the following criteria:

  • Written informed consent has been obtained from the parent(s)/legally acceptable representative (LAR).
  • Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
  • Child is between 24 months ±1 week to 36 months ±1 week.
  • 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.
  • 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:

  • Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or growth.
  • History of bone, malabsorption, metabolic, congenital or chromosomal abnormality known to affect feeding or growth.
  • Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment.
  • Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or severe food allergies that impact diet.
  • Current breast milk feeding in place of all other milk, and/or milk alternatives.
  • Clinical signs of severe micronutrient deficiencies.
  • Parents not willing / not able to comply with the requirements of study protocol.
  • Child's participation in another interventional clinical trial.

Treatment and study plan

Traditional cow's milk

Other

Fortified cow's milk

Experimental milk

Other

Milk with synbiotics and fat blend

habitual diet

Other

Habitual diet

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. Stool analyses

    Time frame: Day 1, Day 180

    Excretion of fecal calcium fatty acid soaps

  8. Stool analyses

    Time frame: Day 1, Day 180

    Measurement of stool calcium content

  9. Serum vitamin D

    Time frame: Day 1, Day 180

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

  10. 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)

  11. 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)

  12. 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.

  13. Stool analyses

    Time frame: Day 1, Day 180

    Determination of fecal short chain fatty acids (SCFAs)

  14. Stool analyses

    Time frame: Day 1, Day 180

    Fecal pH and metabolism.

  15. Stool analyses

    Time frame: Day 1, Day 180

    Fecal markers of gut health

  16. 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.

  17. Vitamin B

    Time frame: Day 1, Day 180

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

  18. 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.

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

    Time frame: Day 1, Day 180

    assessed using the parent-reported questionnaires

  20. Outdoor Playtime

    Time frame: Day 1 and Day 180

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

  21. 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.

Other outcomes

  1. Anthropometry

    Time frame: Day 1, Day 180

    Measurement of weight

  2. Anthropometry

    Time frame: Day 1, Day 180

    Measurement of height

  3. Anthropometry

    Time frame: Day 1, Day 180

    Measurement of head circumference

  4. 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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.