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

NCT ID: NCT04768933

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-11
• Study Completion Date: 2020-12-12

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.

Conditions

Digestion; Happiness; Temperament

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Toddler Milk

Intervention Type: DIETARY_SUPPLEMENT

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).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 33 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai China-norm Information Technology co., LTD

Shanghai, , China

Countries

China

Other Identifiers

20.14.INF

Identifier Type: -

Identifier Source: org_study_id