Digestion, Happiness, Temperament
Conditions
Keywords
prebiotic, digestion, child development, temperament
Brief summary
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).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTToddler Milk
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).
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 33 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digestive tolerance | Baseline (week 0) and week 4 (Day 28±2) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child's emotional expressions | at weeks 0 (baseline), 1 (Day 7±2), 2 (Day 14±2), and 4 (Day 28±2). | 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. |
| Milk Satisfaction | at weeks 0 (baseline), 1 (Day 7±2) and 4 (Day 28±2). | 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. |
| Temperament | from baseline (week 0) to week 4 (Day 28±2) | Change in temperament surgency scores derived from the Children's Behavior Questionnaire (CBQ), short version |
| Height in centimeters | at week 0 (baseline) and week 4 (Day 28±2) | Height (cm) will be taken for the purpose of assessing child's growth |
| Milk intake | at baseline and prospectively during transition period (Day 1-3) and for three consecutive days on week 1 (Day 7±2), 2 (Day 14±2) and 4 (Day 28±2). | based on 24-hour recall of dairy and non-dairy intake obtained from the Milk Intake Questionnaire |
| Weight in kilograms | at week 0 (baseline) and week 4 (Day 28±2) | Weight (kg) will be taken for the purpose of assessing child's growth |
Countries
China
Outcome results
None listed