Clinical trial NCT04799028: Evaluation of Toddler Milk Containing L.Reuteri, Galacto-oligosaccharides and Palm-Oil Free Fat Blend
Official title: Evaluation of Toddler Milk Containing L.Reuteri, Galacto-oligosaccharides and Palm-Oil Free Fat Blend On Bone Metabolism Among Healthy Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toddlers Bone Metabolism
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 273
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Speed of sound (SOS)
timeFrame: Day 1, Day 90, Day 180
Secondary outcomes:
measure: GI tolerance and stooling patterns
timeFrame: Day 1
measure: GI tolerance and stooling patterns
timeFrame: Day 1
measure: GI tolerance and stooling patterns
timeFrame: Day 90, Day 180
measure: GI tolerance and stooling patterns
timeFrame: Day 90, Day 180
measure: GI tolerance and stooling patterns
timeFrame: Day 1, Day 90, Day 180
measure: GI tolerance and stooling patterns
timeFrame: Day 1, Day 90, Day 180
measure: Stool analyses
timeFrame: Day 1, Day 180
measure: Stool analyses
timeFrame: Day 1, Day 180
measure: Serum vitamin D
timeFrame: Day 1, Day 180
measure: Urine and Blood bone turnover markers
timeFrame: Day 1, Day 180 (EXPL and CTRL groups only)
measure: Urine and Blood bone turnover markers
timeFrame: Day 1, Day 180 (EXPL and CTRL groups only
measure: Gut microbiota
timeFrame: Day 1, Day 180
measure: Stool analyses
timeFrame: Day 1, Day 180
measure: Stool analyses
timeFrame: Day 1, Day 180
measure: Stool analyses
timeFrame: Day 1, Day 180
measure: Physical strength
timeFrame: Day 1, Day 180
measure: Vitamin B
timeFrame: Day 1, Day 180
measure: Dietary intake patterns
timeFrame: Day 1, Day 180
measure: Child quality of life using validated ITQOL SF-47 questionnaire
timeFrame: Day 1, Day 180
measure: Outdoor Playtime
timeFrame: Day 1 and Day 180
measure: Child temperament
timeFrame: Day 1, Day 180
Other outcomes:
measure: Anthropometry
timeFrame: Day 1, Day 180
measure: Anthropometry
timeFrame: Day 1, Day 180
measure: Anthropometry
timeFrame: Day 1, Day 180
measure: Safety endpoints
timeFrame: Day 1, Day 180 and follow up of 14 days after last intake of study products
Locations:
city: Muntinlupa
country: Philippines
facility: Asian Foundation for Tropical Medicine, Inc.
Study officials:
References: