Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sense of Well-being When Consuming a New Toddler Milk

Société des Produits Nestlé (SPN)100 enrolled

Overview

This is a prospective, open-label, single-arm study in a real-world setting of healthy Chinese toddlers provided with new toddler milk for a total of 4 weeks (28 days).

The new toddler milk contains prebiotic and an optimized fat blend of bovine milk fat, vegetable fats, and a LC-PUFA oil mixture (providing DHA and ARA). The prebiotic and bovine milk fat-based blend have shown to be able to improve digestive comfort and milk taste. Physiological factors such as physical discomfort has been shown to be associated with negative emotionality and temperament (Putnam 2012). Therefore, the investigators hypothesize that by improving digestive comfort, they are able to influence child temperament, happiness, and other behavioral characteristics.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Digestion Happiness Temperament

Interventions

Toddler MilkDIETARY_SUPPLEMENT

At least three 130 mL servings daily of study formula are recommended for a total daily intake of 390 mL. Study participants will continue this feeding regimen Days 4 to 28 (approximately 4 weeks).

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 33 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Generally healthy toddlers born at term (37-42 weeks of gestation). 2. At enrolment visit, toddler age 12-33 months. 3. Birth weight ≥ 2500g and ≤ 4500g. 4. No known milk intolerance / allergies to cow's milk protein. 5. Habitually consuming some cow's milk or other traditional milks. Exclusion Criteria: 1. Toddler is currently breastfed or is consuming breast milk. 2. Toddler who is experiencing growth faltering (defined as weight for length z score ≤-1.67). 3. History of preterm birth 4. Currently experiencing severe constipation. 5. Currently diagnosed with other Functional Gastrointestinal Disorders. 6. Toddlers who have known cognitive and developmental disorders. 7. Toddlers who are currently participating in or have participated in another clinical trial within 4 weeks prior to trial start.

Locations (1)

Shanghai China-norm Information Technology co., LTD

Shanghai, China

Outcomes

Primary Outcomes

Digestive tolerance

Change in overall digestive tolerance composite scores measured by the Toddler Gut Comfort Questionnaire consisting of 10 questions on parent perceptions of constipation, diarrhea, gassiness, abdominal pain, bloating and other GI-related behaviors.

Time frame: Baseline (week 0) and week 4 (Day 28±2)

Secondary Outcomes

Temperament

Change in temperament surgency scores derived from the Children's Behavior Questionnaire (CBQ), short version

Time frame: from baseline (week 0) to week 4 (Day 28±2)

Child's emotional expressions

Child's emotional expressions such as Happy, Smiling, Surprised, Anger, and Disgust derived from the Anura phone app. In addition, parents will report child's mood including being happy, relaxed and smiling in the Mood Diary.

Time frame: at weeks 0 (baseline), 1 (Day 7±2), 2 (Day 14±2), and 4 (Day 28±2).

Milk Satisfaction

Milk Satisfaction derived from a toddler and parent-reported brief (9-items) Milk Satisfaction Questionnaire The questionnaire consists of questions regarding taste, sweetness, milky taste, nutritional profile, and convenience.

Time frame: at weeks 0 (baseline), 1 (Day 7±2) and 4 (Day 28±2).

Weight in kilograms

Weight (kg) will be taken for the purpose of assessing child's growth

Time frame: at week 0 (baseline) and week 4 (Day 28±2)

Height in centimeters

Height (cm) will be taken for the purpose of assessing child's growth

Time frame: at week 0 (baseline) and week 4 (Day 28±2)

Data from ClinicalTrials.gov

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