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

• ClinicalTrials.gov Identifier: NCT04768933
• Recruitment Status: Completed
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Sponsor: Nestlé
• Information provided by (Responsible Party): Nestlé

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Digestion; Happiness; Temperament	Dietary Supplement: Toddler Milk	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: October 11, 2020
• Actual Primary Completion Date: November 28, 2020
• Actual Study Completion Date: December 12, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Toddler Milk Group; 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.	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).

Outcome Measures

Primary Outcome Measures :

1. Digestive tolerance [ 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.

Secondary Outcome Measures :

1. Temperament [ 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
2. Child's emotional expressions [ 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.
3. Milk Satisfaction [ 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.
4. Weight in kilograms [ 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
5. Height in centimeters [ 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
6. Milk intake [ 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

Eligibility Criteria

• Ages Eligible for Study: 12 Months to 33 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

China

Shanghai China-norm Information Technology co., LTD

Shanghai, China, 200000

Sponsors and Collaborators

Nestlé

More Information

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT04768933
• Other Study ID Numbers: 20.14.INF
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nestlé:

prebiotic; digestion; child development; temperament