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

Happiness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768933
• Other study ID #: 20.14.INF
• Status: Completed
• Phase: N/A
• Start date: October 11, 2020
• Est. completion date: December 12, 2020

Study information

• Verified date: February 2021
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 12, 2020
• Est. primary completion date: November 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 33 Months

Eligibility

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.

Related Conditions & MeSH terms

• Digestion
• Happiness
• Temperament

Intervention

Dietary Supplement:
• Toddler 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).

Locations

Country	Name	City	State
China	Shanghai China-norm Information Technology co., LTD	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (week 0) and week 4 (Day 28±2)
Secondary	Temperament	Change in temperament surgency scores derived from the Children's Behavior Questionnaire (CBQ), short version	from baseline (week 0) to week 4 (Day 28±2)
Secondary	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.	at weeks 0 (baseline), 1 (Day 7±2), 2 (Day 14±2), and 4 (Day 28±2).
Secondary	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.	at weeks 0 (baseline), 1 (Day 7±2) and 4 (Day 28±2).
Secondary	Weight in kilograms	Weight (kg) will be taken for the purpose of assessing child's growth	at week 0 (baseline) and week 4 (Day 28±2)
Secondary	Height in centimeters	Height (cm) will be taken for the purpose of assessing child's growth	at week 0 (baseline) and week 4 (Day 28±2)
Secondary	Milk intake	based on 24-hour recall of dairy and non-dairy intake obtained from the Milk Intake Questionnaire	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).