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

Nestlé

Status: Completed

Conditions: Happiness; Temperament; Digestion

Treatments: Dietary Supplement: Toddler Milk

Study type: Interventional

Funder types: Industry

Identifiers

NCT04768933

20.14.INF

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 12 to 33 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Toddler Milk Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Toddler Milk