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

Not Applicable

Completed

• Conditions: Digestion; Temperament; Happiness
• Interventions: Dietary Supplement: Toddler Milk

• Registration Number: NCT04768933
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2020-10-11
• Primary Completion: 2020-11-28
• Study Completion: 2020-12-12
• Study First Submitted: 2020-12-17
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-23
• Last Update Submitted: 2021-02-23
• Study First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Toddler Milk Group	Toddler Milk	All enrolled subjects with be provided a new toddler milk for 28 days. Aligned with clinical and label recommendations, they will be required to intake at least 3 servings of 130 ml per day.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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
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

Trial Locations

Locations (1)

Shanghai China-norm Information Technology co., LTD; 🇨🇳 Shanghai, China