Shanghai China-norm Information Technology co., LTD
Shanghai, 200000, China
NCT Number: NCT04768933
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).
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Notify Me12 month–33 month
All sexes
Interventional
Not applicable
Shanghai, 200000, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: at week 0 (baseline) and week 4 (Day 28±2)
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 (cm) will be taken for the purpose of assessing child's growth
Time frame: 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
Société des Produits Nestlé (SPN)
Industry
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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.
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