Evaluation of Toddler Milk Containing L.Reuteri, Galacto-oligosaccharides and Palm-Oil Free Fat Blend On Bone Metabolism Among Healthy Toddlers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 273
- 试验地点
- 2
- 主要终点
- Speed of sound (SOS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study is a double-blinded study. The identity of specific product will be masked to subjects, support staff, investigators and sponsor's personnel except the manufacture and quality unit at Nestle (production factory).
入排标准
- 年龄范围
- 2 Years 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Speed of sound (SOS)
时间窗: Day 1, Day 90, Day 180
Speed of sound (SOS) using a quantitative ultrasound methods measured by Pediatric Sunlight 9000 device
次要结局
- Serum vitamin D(Day 1, Day 180)
- Urine and Blood bone turnover markers(Day 1, Day 180 (EXPL and CTRL groups only)
- Gut microbiota(Day 1, Day 180)
- Physical strength(Day 1, Day 180)
- Vitamin B(Day 1, Day 180)
- Dietary intake patterns(Day 1, Day 180)
- Child quality of life using validated ITQOL SF-47 questionnaire(Day 1, Day 180)
- Outdoor Playtime(Day 1 and Day 180)
- Child temperament(Day 1, Day 180)
- Stool analyses(Day 1, Day 180)
- GI tolerance and stooling patterns(Day 1, Day 90, Day 180)